Defining therapy parameter values for posture states

ABSTRACT

The disclosure is directed towards posture-responsive therapy. To avoid interruptions in effective therapy, an implantable medical device may include a posture state module that detects the posture state of the patient and automatically adjusts therapy parameter values according to the detected posture state. A system may include an external programmer comprising a user interface that receives user input defining therapy parameter values for delivery of therapy to a patient, and user input associating one or more of the therapy parameter values with a plurality of posture states based on user input, a processor that automatically defines therapy parameter values for delivery of therapy to a patient when the patient occupies the posture states based on the association, and an implantable medical device that delivers the therapy to the patient in response to detection of the posture states.

This application claims the benefit of U.S. Provisional Application Ser.No. 61/080,089, to Skelton et al., filed Jul. 11, 2008, and entitled“POSTURE STATE MANAGEMENT FOR POSTURE-RESPONSIVE THERAPY,” which isincorporated herein by reference in its entirety.

TECHNICAL FIELD

The disclosure relates to medical devices and, more particularly, toprogrammable medical devices that deliver therapy.

BACKGROUND

A variety of medical devices are used for chronic, e.g., long-term,delivery of therapy to patients suffering from a variety of conditions,such as chronic pain, tremor, Parkinson's disease, epilepsy, urinary orfecal incontinence, sexual dysfunction, obesity, or gastroparesis. Asexamples, electrical stimulation generators are used for chronicdelivery of electrical stimulation therapies such as cardiac pacing,neurostimulation, muscle stimulation, or the like. Pumps or other fluiddelivery devices may be used for chronic delivery of therapeutic agents,such as drugs. Typically, such devices provide therapy continuously orperiodically according to parameters contained within a program. Aprogram may comprise respective values for each of a plurality ofparameters, specified by a clinician.

In some cases, the patient may be allowed to activate and/or modify thetherapy delivered by the medical device. For example, a patient may beprovided with a patient programming device. The patient programmingdevice communicates with a medical device to allow the patient toactivate therapy and/or adjust therapy parameters. For example, animplantable medical device (IMD), such as an implantableneurostimulator, may be accompanied by an external patient programmerthat permits the patient to activate and deactivate neurostimulationtherapy and/or adjust the intensity of the delivered neurostimulation.The patient programmer may communicate with the IMD via wirelesstelemetry to control the IMD and/or retrieve information from the IMD.

SUMMARY

In general, the disclosure is directed to posture state-responsivetherapy. The disclosure contemplates a variety of features for managingassociation of therapy parameter values with different posture states tosupport posture state-responsive therapy. To deliver posturestate-responsive therapy, an IMD detects a posture state of the patient,and adjusts therapy delivered to the patient according to the detectedposture state.

A posture state may refer to a patient posture or a combination ofpatient posture and activity. As a patient's posture state changes,therapy can be adjusted to accommodate differences in symptoms orpatient response to therapy. Adjustments to therapy may includeselection of different therapy programs and/or adjustments to one ormore therapy parameter values associated with one or more therapyprograms.

A programmer for an implantable medical device may provide a variety offeatures to support association of therapy parameter values withdifferent posture states. As an example, a patient may indicate a valuefor a previously undefined therapy parameter value for a defined posturestate while the patient is in the posture state or transitioning to theposture state. The indicated value may be defined for the posture state.As another example, a user may link multiple posture states and select aset of therapy parameter values for delivery of therapy for each of thelinked posture states. In this manner, it may not be necessary tospecify separate sets of therapy parameter values for each individualposture state.

Also, a user may define therapy parameter values for delivery of therapyto a patient and associate the therapy parameter values with multipleposture states based on user input, e.g., simultaneously. As anotherexample, upon storing a set of pre-established posture state definitionsfor delivery of posture state-responsive therapy, a device may permit apatient to submit a request via a patient programmer to update the setof pre-established posture state definitions.

As another feature, upon delivering therapy to a patient according to aset of therapy parameter values while the patient occupies a firstposture state, one or more of the therapy parameter values may beassociated with a second posture state different from the first posturestate based on patient input. This feature may permit association oftherapy parameter values with the second posture state without requiringthe patient to actually occupy that posture state.

As an additional feature, a posture state definition may be modifiedbased on user therapy adjustments and/or posture state information. Insome cases, the posture state may be expanded and split. In other cases,the posture state may be reduced in size based on posture stateinformation. Hence, using one or more of the features described in thisdisclosure, therapy parameter values may be flexibly, conveniently, andefficiently specified for various posture states, includingpredetermined posture states and patient-created posture states.

In one example, the disclosure provides a method comprising defining aplurality of posture states for a patient, defining therapy parametervalues for at least some of the posture states, receiving patient inputindicating a value for a previously undefined therapy parameter valuefor one of the defined posture states while the patient is in therespective posture state or transitioning to the respective posturestate, and defining the previously undefined therapy parameter value forthe respective posture state based on the patient input.

In another example, the disclosure provides a system comprising a memorythat stores a definition of a plurality of posture states for a patientand a definition of therapy parameter values for at least some of theposture states, an external programmer comprising a user interface thatreceives patient input indicating a value for a previously undefinedtherapy parameter value for one of the defined posture states while thepatient is in the respective posture state or transitioning to therespective posture state, a processor that defines the previouslyundefined therapy parameter value for the respective posture state basedon the patient input, and an implantable medical device that detects theposture states, and delivers therapy to the patient input using thetherapy parameter values defined for the detected posture states.

In another example, the disclosure provides a method comprising linkinga plurality of posture states of a patient, selecting a set of therapyparameter values for delivery of therapy to the patient by animplantable medical device for each of the linked posture states; anddefining the therapy to be delivered to the patient by the implantablemedical device for each of the linked posture states based on theselection.

In another example, the disclosure provides an external programmer foran implantable medical device, the programmer comprising a userinterface that receives user input linking a plurality of posture statesof a patient, and selecting a set of therapy parameter values fordelivery of therapy to the patient by the implantable medical device foreach of a linked posture states, and a processor that defines thetherapy to be delivered to the patient by the implantable medical devicefor each of the linked posture states based on the selection.

In another example, the disclosure provides a system comprising a userinterface that receives user input linking a plurality of posture statesof a patient, and selecting a set of therapy parameter values fordelivery of therapy to the patient for each of a linked posture states,a processor that defines the therapy to be delivered to the patient foreach of the linked posture states based on the selection, and animplantable medical device that delivers the therapy to the patient foreach of the linked posture states based on the selection.

In another example, the disclosure provides a method comprising definingtherapy parameter values for delivery of therapy to a patient,associating one or more of the therapy parameter values with a pluralityof posture states based on user input, and automatically definingtherapy parameter values for delivery of therapy to a patient when thepatient occupies the posture states based on the association.

In another example, the disclosure provides an external programmer foran implantable medical device, the programmer comprising a userinterface that receives user input defining therapy parameter values fordelivery of therapy to a patient, and user input associating one or moreof the therapy parameter values with a plurality of posture states basedon user input, and a processor that automatically defining therapyparameter values for delivery of therapy to a patient when the patientoccupies the posture states based on the association.

In another example, the disclosure provides a system comprising anexternal programmer comprising a user interface that receives user inputdefining therapy parameter values for delivery of therapy to a patient,and user input associating one or more of the therapy parameter valueswith a plurality of posture states based on user input, a processor thatautomatically defining therapy parameter values for delivery of therapyto a patient when the patient occupies the posture states based on theassociation, and an implantable medical device that delivers the therapyto the patient in response to detection of the posture states.

In another example, the disclosure provides a method comprising storinga set of pre-established posture state definitions for delivery ofposture state-responsive therapy to a patient, receiving a request froma patient via a patient programmer to update the set of pre-establishedposture state definitions, and updating the set of pre-establishedposture state definitions in response to the request.

In another example, the disclosure provides an external programmercomprising a user interface that receives a request from a user toupdate a set of pre-established posture state definitions for deliveryof posture responsive therapy to a patient, and a processor that updatesthe set of pre-established posture state definitions in response to therequest.

In another example, the disclosure provides a system comprising a memorythat stores a set of pre-established posture state definitions fordelivery of posture responsive therapy to a patient, an externalprogrammer comprising a user interface that receives a request from auser to update the set of pre-established posture state definitions, anda processor that updates the set of pre-established posture statedefinitions in response to the request.

In another example, the disclosure provides a method comprisingreceiving a request from a user to add a new posture state to a set ofposture state definitions for delivery of posture responsive therapy toa patient, receiving a graphical representation of a desired location ofthe new posture state from the user, and defining the new posture statebased on the desired location in response to the request.

In another example, the disclosure provides a method comprisingdelivering therapy to a patient according to a set of therapy parametervalues while the patient occupies a first posture state, associating oneor more of the therapy parameter values with a second posture statedifferent from the first posture state based on patient input, andautomatically defining therapy for delivery to the patient when thepatient occupies the second posture state based on the associatedtherapy parameter values.

In another example, the disclosure provides a system comprising animplantable medical device that delivers therapy to a patient accordingto a set of therapy parameter values while the patient occupies a firstposture state, a user interface that receives patient input associatingone or more of the therapy parameter values with a second posture statedifferent from the first posture state, and a processor thatautomatically defines therapy for delivery to the patient when thepatient occupies the second posture state based on the associatedtherapy parameter values.

In another example, the disclosure provides an external programmer foran implantable medical device, the programmer comprising a userinterface that receives patient input associating one or more therapyparameter values of therapy delivered from the implantable medicaldevice to a patient when the patient occupies a first posture state witha second posture state different from the first posture state, and aprocessor that automatically defines therapy for delivery from theimplantable medical device to the patient when the patient occupies thesecond posture state based on the associated therapy parameter values.

In another example, the disclosure provides a method comprisingrecording a plurality of postures of a patient over a period of time,identifying a set of the plurality of postures that fall within aposture state, and redefining a boundary of the posture state based onwhere the postures fall within the posture state.

In another example, the disclosure provides a system comprising a memorythat stores posture state definitions, a posture state module thatrecords a plurality of postures of a patient over a period of time, anda processor that identifies a set of the plurality of postures that fallwithin a posture state, and redefines a boundary of the posture statebased on where the postures fall within the posture state.

In another example, the disclosure provides a method comprisingrecording a therapy adjustment and a posture of a patient correspondingto the therapy adjustment, determining whether the posture falls withina defined posture state, comparing the therapy adjustment to therapyinformation associated with the defined posture state, and updating aset of posture state definitions based on the determination andcomparison.

In another example, the disclosure provides a system comprising aposture state module that records a current posture of a patient, a userinterface that receives a therapy adjustment, a processor thatassociates a posture that the posture state module recorded when theuser interface received the therapy adjustment with the therapyadjustment, determines whether the posture falls within a definedposture state, compares the therapy adjustment to therapy informationassociated with the defined posture state, and updates the set ofposture state definitions based on the determination and comparison.

The details of one or more embodiments of the disclosure are set forthin the accompanying drawings and the description below. Other features,objects, and advantages of the disclosure will be apparent from thedescription and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a conceptual diagram illustrating an implantable stimulationsystem including two implantable stimulation leads.

FIG. 1B is a conceptual diagram illustrating an implantable stimulationsystem including three implantable stimulation leads.

FIG. 1C is a conceptual diagram illustrating an implantable drugdelivery system including a delivery catheter.

FIG. 2 is a conceptual diagram illustrating an example patientprogrammer for programming stimulation therapy delivered by animplantable medical device.

FIG. 3 is a conceptual diagram illustrating an example clinicianprogrammer for programming stimulation therapy delivered by animplantable medical device.

FIG. 4 is a functional block diagram illustrating various components ofan implantable electrical stimulator.

FIG. 5 is a functional block diagram illustrating various components ofan implantable drug pump.

FIG. 6 is a functional block diagram illustrating various components ofan external programmer for an implantable medical device.

FIG. 7 is a block diagram illustrating an example system that includesan external device, such as a server, and one or more computing devicesthat are coupled to an implantable medical device and externalprogrammer shown in FIGS. 1A-1C via a network.

FIGS. 8A-8C are conceptual illustrations of example posture state spaceswithin which postures state reference data may define the posture stateof a patient.

FIG. 9 is a conceptual diagram illustrating example posture search andposture stability timers with one posture state.

FIG. 10 is a conceptual diagram illustrating example posture search andposture stability timers with one change in posture states.

FIG. 11 is a conceptual diagram illustrating example posture search andposture stability timers with two changes in posture states.

FIG. 12 is a conceptual diagram illustrating example posture search andposture stability timers with the last posture state change occurringoutside of the posture search timer.

FIG. 13 is a flow diagram illustrating an example method for associatinga received therapy adjustment with a posture state.

FIG. 14 is a conceptual diagram illustrating an example user interfaceof a patient programmer for delivering therapy information to thepatient.

FIG. 15 is a conceptual diagram illustrating an example user interfaceof a patient programmer for delivering therapy information that includesposture information to the patient.

FIG. 16 is a conceptual diagram illustrating an example screen that maybe displayed by a user interface of a clinician programmer to permit auser to link posture states together for posture state-responsivetherapy.

FIGS. 17A-17C are conceptual diagrams illustrating example screens thatmay be displayed by a user interface of a clinician programmer to allowa user to select which program groups to apply for posture-responsivetherapy.

FIGS. 18A-18D are conceptual diagrams illustrating example screens thatmay be displayed by a user interface of a clinician programmer topresent therapy information for various posture states to a user, suchas a clinician.

FIG. 19 is a conceptual diagram illustrating an example screen that maybe displayed by a user interface of a clinician programmer to allow auser to save the current therapy settings to one or more posture states.

FIG. 20 is a conceptual illustration of posture cones used to define aposture state of a patient via a posture state sensor of a posture statemodule.

FIG. 21 is a conceptual illustration of a posture cone that isautomatically redefined based on recorded posture vectors.

FIG. 22 is a flow diagram illustrating an example method for updatingposture state definitions when a recorded posture vector associated withtherapy adjustment falls within a defined posture state.

FIG. 23 is a flow diagram illustrating an example method for updatingposture state definitions when a recorded posture vector associated witha therapy adjustment falls outside of the defined posture states

FIGS. 24-26 are flow charts illustrating some of the techniquesdescribed in this disclosure.

DETAILED DESCRIPTION

In some medical devices that deliver electrical stimulation therapy,therapeutic efficacy may change as the patient changes posture states.In general, a posture state may refer to a posture or a combination ofposture and activity. Efficacy may refer, in general, to a combinationof complete or partial alleviation of symptoms alone, or in combinationwith a degree of undesirable side effects.

Changes in posture state may cause changes in efficacy due to changes indistances between electrodes or other therapy delivery elements, e.g.,due to temporary migration of leads or catheters caused by forces orstresses associated with different postures, or from changes incompression of patient tissue in different posture states. Also, posturestate changes may present changes in symptoms or symptom levels, e.g.,pain level. For example, for a given patient, sitting may be morepainful on the patient's back than standing regardless of any migrationor compression of the therapy delivery elements. To maintain therapeuticefficacy, it may be desirable to adjust therapy parameters based ondifferent postures and/or activities engaged by the patient to maintaineffective stimulation therapy. Therapy parameters may be adjusteddirectly or by selecting different programs or groups of programsdefining different sets of therapy parameters.

A change in efficacy due to changes in posture state may require thepatient to continually manage therapy by manually adjusting certaintherapy parameters, such as amplitude, pulse rate, or pulse width, orselecting different therapy programs to achieve more efficacious therapythroughout many different posture states. In some cases, a medicaldevice may employ a posture state detector that detects the patientposture state. The medical device may adjust therapy parameters inresponse to different posture states as indicated by the posture statedetector.

For posture state-responsive therapy, therapy adjustments in response todifferent posture states may be fully automatic or semi-automatic in thesense that a user may provide approval of proposed changes. Thedisclosure contemplates a variety of techniques for managing associationof therapy parameter values with different posture states.

As will be described, such techniques may include permitting a patientto define one or more therapy parameter values associated with differentposture states and/or permitting a patient to create new posture statesand specify associated therapy parameter values for such posture states.In addition, such techniques may permit a user to link multiple posturestates together such that one set of therapy parameter values isassociated with the set of linked posture states, associate therapyparameter values with multiple posture states simultaneously, and/orassociate therapy parameter values with a posture state withoutrequiring the patient to actually occupy that posture state. As anotherexample, posture state definitions may be automatically updated, e.g.,based on recorded posture vector and therapy adjustment data. Hence,therapy parameter values may be flexibly, conveniently, and efficientlyspecified for various posture states, including predetermined posturestates and patient-created posture states.

FIG. 1A is a schematic diagram illustrating an implantable stimulationsystem 10 including a pair of implantable electrode arrays in the formof stimulation leads 16A and 16B. Although the techniques described inthis disclosure may be generally applicable to a variety of medicaldevices including external and implantable medical devices (IMDs),application of such techniques to IMDs and, more particularly,implantable electrical stimulators such as neurostimulators will bedescribed for purposes of illustration. More particularly, thedisclosure will refer to an implantable spinal cord stimulation (SCS)system for purposes of illustration, but without limitation as to othertypes of medical devices.

As shown in FIG. 1A, system 10 includes an IMD 14 and externalprogrammer 20 shown in conjunction with a patient 12. In the example ofFIG. 1A, IMD 14 is an implantable electrical stimulator configured forSCS, e.g., for relief of chronic pain or other symptoms. Again, althoughFIG. 1A shows an implantable medical device, other embodiments mayinclude an external stimulator, e.g., with percutaneously implantedleads. Stimulation energy is delivered from IMD 14 to spinal cord 18 ofpatient 12 via one or more electrodes of implantable leads 16A and 16B(collectively “leads 16”). In some applications, such as SCS to treatchronic pain, the adjacent implantable leads 16 may have longitudinalaxes that are substantially parallel to one another.

Although FIG. 1A is directed to SCS therapy, system 10 may alternativelybe directed to any other condition that may benefit from stimulationtherapy. For example, system 10 may be used to treat tremor, Parkinson'sdisease, epilepsy, urinary or fecal incontinence, sexual dysfunction,obesity, or gastroparesis. In this manner, system 10 may be configuredto provide therapy taking the form of deep brain stimulation (DBS),pelvic floor stimulation, gastric stimulation, or any other stimulationtherapy. In addition, patient 12 is ordinarily a human patient.

Each of leads 16 may include electrodes (not shown in FIG. 1), and theparameters for a program that controls delivery of stimulation therapyby IMD 12 may include information identifying which electrodes have beenselected for delivery of stimulation according to a stimulation program,the polarities of the selected electrodes, i.e., the electrodeconfiguration for the program, and voltage or current amplitude, pulserate, and pulse width of stimulation delivered by the electrodes.Delivery of stimulation pulses will be described for purposes ofillustration. However, stimulation may be delivered in other forms suchas continuous waveforms. Programs that control delivery of othertherapies by IMD 12 may include other parameters, e.g., such as dosageamount, rate, or the like for drug delivery.

In the example of FIG. 1A, leads 16 carry one or more electrodes thatare placed adjacent to the target tissue of the spinal cord. One or moreelectrodes may be disposed at a distal tip of a lead 16 and/or at otherpositions at intermediate points along the lead. Leads 16 may beimplanted and coupled to IMD 14. Alternatively, as mentioned above,leads 16 may be implanted and coupled to an external stimulator, e.g.,through a percutaneous port. In some cases, an external stimulator maybe a trial or screening stimulation that is used on a temporary basis toevaluate potential efficacy to aid in consideration of chronicimplantation for a patient. In additional embodiments, IMD 14 may be aleadless stimulator with one or more arrays of electrodes arranged on ahousing of the stimulator rather than leads that extend from thehousing.

The stimulation may be delivered via selected combinations of electrodescarried by one or both of leads 16. The target tissue may be any tissueaffected by electrical stimulation energy, such as electricalstimulation pulses or waveforms. Such tissue includes nerves, smoothmuscle, and skeletal muscle. In the example illustrated by FIG. 1A, thetarget tissue is spinal cord 18. Stimulation of spinal cord 18 may, forexample, prevent pain signals from traveling through the spinal cord andto the brain of the patient. Patient 12 may perceive the interruption ofpain signals as a reduction in pain and, therefore, efficacious therapyresults.

The deployment of electrodes via leads 16 is described for purposes ofillustration, but arrays of electrodes may be deployed in differentways. For example, a housing associated with a leadless stimulator maycarry one or more arrays of electrodes, e.g., rows and/or columns (orother patterns), to which shifting operations may be applied. Suchelectrodes may be arranged as surface electrodes, ring electrodes, orprotrusions. As a further alternative, electrode arrays may be formed byrows and/or columns of electrodes on one or more paddle leads. In someembodiments, electrode arrays may include electrode segments, which maybe arranged at respective positions around a periphery of a lead, e.g.,arranged in the form of one or more segmented rings around acircumference of a cylindrical lead.

In the example of FIG. 1A, stimulation energy is delivered by IMD 14 tothe spinal cord 18 to reduce the amount of pain perceived by patient 12.As described above, IMD 14 may be used with a variety of different paintherapies, such as peripheral nerve stimulation (PNS), peripheral nervefield stimulation (PNFS), DBS, cortical stimulation (CS), pelvic floorstimulation, gastric stimulation, and the like. The electricalstimulation delivered by IMD 14 may take the form of electricalstimulation pulses or continuous stimulation waveforms, and may becharacterized by controlled voltage levels or controlled current levels,as well as pulse width and pulse rate in the case of stimulation pulses.

In exemplary embodiments, IMD 14 delivers stimulation therapy accordingto one or more programs. A program defines one or more parameters thatdefine an aspect of the therapy delivered by IMD 14 according to thatprogram. For example, a program that controls delivery of stimulation byIMD 14 in the form of pulses may define a voltage or current pulseamplitude, a pulse width, a pulse rate, for stimulation pulses deliveredby IMD 14 according to that program. Moreover, therapy may be deliveredaccording to multiple programs, wherein multiple programs are containedwithin each of a plurality of groups.

Each program group may support an alternative therapy selectable bypatient 12, and IMD 14 may deliver therapy according to the multipleprograms in a group. IMD 14 may rotate through the multiple programs ofthe group when delivering stimulation such that numerous conditions ofpatient 12 are treated. As an illustration, in some cases, stimulationpulses formulated according to parameters defined by different programsmay be delivered on a time-interleaved basis. For example, a group mayinclude a program directed to leg pain, a program directed to lower backpain, and a program directed to abdomen pain. In this manner, IMD 14 maytreat different symptoms substantially simultaneously.

During use of IMD 14 to treat patient 12, movement of patient 12 amongdifferent posture states may affect the ability of IMD 14 to deliverconsistent efficacious therapy. For example, leads 16 may migrate towardIMD 14 when patient 12 bends over, resulting in displacement ofelectrodes and possible disruption in delivery of effective therapy. Forexample, stimulation energy transferred to target tissue may be reduceddue to electrode migration, causing reduced efficacy in terms of reliefof symptoms such as pain. As another example, leads 16 may be compressedtowards spinal cord 18 when patient 12 lies down. Such compression maycause an increase in the amount of stimulation energy transferred totarget tissue. In this case, the amplitude of stimulation therapy mayneed to be decreased to avoid causing patient 12 additional pain orunusual sensations, which may be considered undesirable side effectsthat undermine overall efficacy.

Many other examples of reduced efficacy due to increased coupling ordecreased coupling of stimulation energy to target tissue may occur dueto changes in posture and/or activity level associated with patientposture state. To avoid or reduce possible disruptions in effectivetherapy due to posture state changes, IMD 14 may include a posture statemodule that detects the posture state of patient 12 and causes the IMD14 to automatically adjust stimulation according to the detected posturestate. For example, a posture state module may include a posture statesensor such as an accelerometer that detects when patient 12 lies down,stands up, or otherwise changes posture.

In response to a posture state indication by the posture state module,IMD 14 may change program group, program, stimulation amplitude, pulsewidth, pulse rate, and/or one or more other parameters, groups orprograms to maintain therapeutic efficacy. When a patient lies down, forexample, IMD 14 may automatically reduce stimulation amplitude so thatpatient 12 does not need to reduce stimulation amplitude manually. Insome cases, IMD 14 may communicate with external programmer 20 topresent a proposed change in stimulation in response to a posture statechange, and receive approval or rejection of the change from a user,such as patient 12 or a clinician, before automatically applying thetherapy change. Additionally, in response to a posture state change, IMD14 may communicate with external programmer 20 to provide a notificationto a user, such a clinician, that patient 12 has potentially experienceda fall.

A user, such as a clinician or patient 12, may interact with a userinterface of external programmer 20 to program IMD 14. Programming ofIMD 14 may refer generally to the generation and transfer of commands,programs, or other information to control the operation of IMD 14. Forexample, external programmer 20 may transmit programs, parameteradjustments, program selections, group selections, or other informationto control the operation of IMD 14, e.g., by wireless telemetry. As oneexample, external programmer 20 may transmit parameter adjustments tosupport therapy changes due to posture changes by patient 12. As anotherexample, a user may select programs or program groups. Again, a programmay be characterized by an electrode combination, electrode polarities,voltage or current amplitude, pulse width, pulse rate, and/or duration.A group may be characterized by multiple programs that are deliveredsimultaneously or on an interleaved or rotating basis.

A user interface of external programmer 20 may indicate to the user theposture state in which the patient 12 currently resides. This patientposture state may be a static posture that does not take into accountactivity level, an activity level that does not take into accountposture, or some combination of the posture and activity level thatdescribes the physical position and movement of patient 12. As anexample, posture may be characterized as one of the following postures:standing, sitting, lying down on back, lying down on front, lying downon left side, lying down on right side. Activity level may becharacterized as one of high, medium and low, or be characterized interms of a numeric scale, e.g., 1-10 or 1-12. In other embodiments,other gradations, e.g., high, medium high, medium, medium low, and low,or other numerical scales may be used to characterize activity level.

A posture state may indicate a combination of one of the above postureswith one of the above activity levels. For some postures, such as lyingdown postures, the posture state may not need to consider activitylevel, as the patient may be less likely to undertake any significantactivity in such postures. In other cases, all posture states may takeinto account posture and activity level, even if there is minimalactivity in a particular posture. Posture state may be determined basedon posture information and/or activity level information generated by aposture state module, which may include one or more accelerometers orother posture or activity level sensors.

A patient posture state may be represented by a posture state indicationpresented by the user interface of programmer 20 as a visible, audible,or tactile indication. When presented as a visible indication, theposture state indication may be, for example, a graphicalrepresentation, a symbolic icon, a textual representation, such as wordor number, an arrow, or any other type of indication. The visibleindication may be presented via a display, such as an a liquid crystaldisplay (LCD), dot matrix display, organic light-emitting diode (OLED)display, touch screen, or the like. In other cases, the visibleindication may be provided in a translucent area that is selectivelybacklit to indicate a posture. An audible indication may be produced byprogrammer 20 as spoken words stating a posture state, or differentaudible tones, different numbers of tones, or other audible informationgenerated by the programmer to indicate posture state. A tactileindication of posture state may be produced by programmer 20, forexample, in the form of different numbers of vibratory pulses deliveredin sequence or vibratory pulses of different lengths, amplitudes, orfrequencies.

Programmer 20 may present multiple indications representative ofdifferent patient posture states. IMD 14 may communicate a patientposture state according to a posture state parameter value sensed by aposture state module to external programmer 20, e.g., by wirelesstelemetry. For example, IMD 14 may transmit a posture state indicationto programmer 20 on a periodic, intermittent or continuous basis or inresponse to a posture state change. Alternatively, programmer 20 mayrequest a posture state indication from IMD 14 on a periodic,intermittent or continuous basis. External programmer 20 then may selectand present the associated posture state indication.

In some cases, external programmer 20 may be characterized as aphysician or clinician programmer if it is primarily intended for use bya physician or clinician. In other cases, external programmer 20 may becharacterized as a patient programmer if it is primarily intended foruse by a patient. A patient programmer is generally accessible topatient 12 and, in many cases, may be a portable device that mayaccompany the patient throughout the patient's daily routine. Ingeneral, a physician or clinician programmer may support selection andgeneration of programs by a clinician for use by IMD 14, whereas apatient programmer may support adjustment and selection of such programsby a patient during ordinary use.

IMD 14 may be constructed with a biocompatible housing, such as titaniumor stainless steel, or a polymeric material such as silicone orpolyurethane, and surgically implanted at a site in patient 12 near thepelvis. IMD 14 may also be implanted in patient 12 at a locationminimally noticeable to patient 12. Alternatively, IMD 14 may beexternal with percutaneously implanted leads. For SCS, IMD 14 may belocated in the lower abdomen, lower back, upper buttocks, or otherlocation to secure IMD 14. Leads 16 may be tunneled from IMD 14 throughtissue to reach the target tissue adjacent to spinal cord 18 forstimulation delivery.

At the distal tips of leads 16 are one or more electrodes (not shown)that transfer the electrical stimulation from the lead to the tissue.The electrodes may be electrode pads on a paddle lead, circular (e.g.,ring) electrodes surrounding the body of leads 16, conformableelectrodes, cuff electrodes, segmented electrodes, or any other type ofelectrodes capable of forming unipolar, bipolar or multipolar electrodeconfigurations for therapy. In general, ring electrodes arranged atdifferent axial positions at the distal ends of leads 16 will bedescribed for purposes of illustration.

FIG. 1B is a conceptual diagram illustrating an implantable stimulationsystem 22 including three implantable stimulation leads 16A, 16B, 16C(collectively leads 16). System 22 generally conforms to system 10 ofFIG. 1A, but includes a third lead. Accordingly, IMD 14 may deliverstimulation via combinations of electrodes carried by all three leads16, or a subset of the three leads. The third lead, e.g., lead 16C, mayinclude a greater number of electrodes than leads 16A and 16B and bepositioned between leads 16A and 16B or on one side of either lead 16Aor 16B. External programmer 20 may be initially told the number andconfiguration of leads 16 in order to appropriately program stimulationtherapy.

For example, leads 16A and 16B could include four electrodes, while lead16C includes eight or sixteen electrodes, thereby forming a so-called4-8-4 or 4-16-4 lead configuration. Other lead configurations, such as8-16-8, 8-4-8, 16-8-16, 16-4-16, are possible. In some cases, electrodeson lead 16C may be smaller in size and/or closer together than theelectrodes of leads 16A or 16B. Movement of lead 16C due to changingactivities or postures of patient 12 may, in some instances, moreseverely affect stimulation efficacy than movement of leads 16A or 16B.Patient 12 may further benefit from the ability of IMD 14 to detectposture states and associated changes and automatically adjuststimulation therapy to maintain therapy efficacy in a three lead system22.

FIG. 1C is a conceptual diagram illustrating an implantable drugdelivery system 24 including one delivery catheter 28 coupled to IMD 26.As shown in the example of FIG. 1C, drug delivery system 24 issubstantially similar to systems 10 and 22. However, drug deliverysystem 24 performs the similar therapy functions via delivery of drugstimulation therapy instead of electrical stimulation therapy. IMD 26functions as a drug pump in the example of FIG. 1C, and IMD 26communicates with external programmer 20 to initialize therapy or modifytherapy during operation. In addition, IMD 26 may be refillable to allowchronic drug delivery.

Although IMD 26 is shown as coupled to only one catheter 28 positionedalong spinal cord 18, additional catheters may also be coupled to IMD26. Multiple catheters may deliver drugs or other therapeutic agents tothe same anatomical location or the same tissue or organ. Alternatively,each catheter may deliver therapy to different tissues within patient 12for the purpose of treating multiple symptoms or conditions. In someembodiments, IMD 26 may be an external device which includes apercutaneous catheter that forms catheter 28 or that is coupled tocatheter 28, e.g., via a fluid coupler. In other embodiments, IMD 26 mayinclude both electrical stimulation as described in IMD 14 and drugdelivery therapy.

IMD 26 may also operate using parameters that define the method of drugdelivery. IMD 26 may include programs, or groups of programs, thatdefine different delivery methods for patient 14. For example, a programthat controls delivery of a drug or other therapeutic agent may includea titration rate or information controlling the timing of bolusdeliveries. Patient 14 may use external programmer 20 to adjust theprograms or groups of programs to regulate the therapy delivery.

Similar to IMD 14, IMD 26 may include a posture state module thatmonitors the patient 12 posture state and adjusts therapy accordingly.For example, the posture state module may indicate that patient 12transitions from lying down to standing up. IMD 26 may automaticallyincrease the rate of drug delivered to patient 12 in the standingposition if patient 12 has indicated that pain increased when standing.This automated adjustment to therapy based upon posture state may beactivated for all or only a portion of the programs used by IMD 26 todeliver therapy.

FIG. 2 is a conceptual diagram illustrating an example patientprogrammer 30 for programming stimulation therapy delivered by animplantable medical device. Patient programmer 30 is an exampleembodiment of external programmer 20 illustrated in FIGS. 1A, 1B and 1Cand may be used with either IMD 14 or IMD 26. In alternativeembodiments, patient programmer 30 may be used with an external medicaldevice. As shown in FIG. 2, patient programmer 30 provides a userinterface (not shown) for a user, such as patient 12, to manage andprogram stimulation therapy. Patient programmer 30 is protected byhousing 32, which encloses circuitry necessary for patient programmer 30to operate.

Patient programmer 30 also includes display 36, power button 38,increase button 52, decrease button 50, sync button 58, stimulation ONbutton 54, and stimulation OFF button 56. Cover 34 protects display 36from being damaged during patient programmer 30 use. Patient programmer30 also includes control pad 40 which allows a user to navigate throughitems displayed on display 36 in the direction of arrows 42, 44, 46, and48. In some embodiments, the buttons and pad 40 may take the form ofsoft keys (e.g., with functions and contexts indicated on display 36),with functionality that may change, for example, based on currentprogramming operation or user preference. In alternative embodiments,display 36 may be a touch screen in which patient 12 may interactdirectly with display 36 without the use of control pad 40 or evenincrease button 52 and decrease button 50.

In the illustrated embodiment, patient programmer 30 is a hand helddevice. Patient programmer 30 may accompany patient 12 throughout adaily routine. In some cases, patient programmer 30 may be used by aclinician when patient 12 visits the clinician in a hospital or clinic.In other embodiments, patient programmer 30 may be a clinicianprogrammer that remains with the clinician or in the clinic and is usedby the clinician and/or patient 12 when the patient is in the clinic. Inthe case of a clinician programmer, small size and portability may beless important. Accordingly, a clinician programmer may be sized largerthan a patient programmer, and it may provide a larger screen for morefull-featured programming.

Housing 32 may be constructed of a polymer, metal alloy, composite, orcombination material suitable to protect and contain components ofpatient programmer 30. In addition, housing 32 may be partially orcompletely sealed such that fluids, gases, or other elements may notpenetrate the housing and affect components therein. Power button 38 mayturn patient programmer 30 ON or OFF as desired by patient 12. Patient12 may control the illumination level, or backlight level, of display 36by using control pad 40 to navigate through the user interface andincrease or decrease the illumination level with decrease and increasebuttons 50 and 52.

In some embodiments, illumination may be controlled by a knob thatrotates clockwise and counter-clockwise to control patient programmer 30operational status and display 36 illumination. Patient programmer 30may be prevented from turning OFF during telemetry with IMD 14 oranother device to prevent the loss of transmitted data or the stallingof normal operation. Alternatively, patient programmer 30 and IMD 14 mayinclude instructions that handle possible unplanned telemetryinterruption, such as battery failure or inadvertent device shutdown.

Display 36 may be a liquid crystal display (LCD), dot matrix display,organic light-emitting diode (OLED) display, touch screen, or similarmonochrome or color display capable of providing visible information topatient 12. Display 36 may provide a user interface regarding currentstimulation therapy, posture state information, provide a user interfacefor receiving feedback or medication input from patient 12, display anactive group of stimulation programs, and display operational status ofpatient programmer 30 or IMD 14 or 26. For example, patient programmer30 may provide a scrollable list of groups, and a scrollable list ofprograms within each group, via display 36.

Control pad 40 allows patient 12 to navigate through items displayed ondisplay 36. Patient 12 may press control pad 40 on any of arrows 42, 44,46, and 48 in order to move to another item on display 36 or move toanother screen not currently shown on the display. In some embodiments,pressing the middle of control pad 40 may select any item highlighted indisplay 36. In other embodiments, scroll bars, a scroll wheel,individual buttons, or a joystick may perform the complete or partialfunctions of control pad 40. In alternative embodiments, control pad 40may be a touch pad that allows patient 12 to move a cursor within theuser interface displayed on display 36 to manage therapy.

Decrease button 50 and increase button 52 provide an input mechanism forpatient 12. In general, decrease button 50 may decrease the value of ahighlighted stimulation parameter every time the decrease button ispressed. In contrast, increase button 52 may increase the value of ahighlighted stimulation parameter one step every time the increasebutton is pressed. While buttons 50 and 52 may be used to control thevalue of any stimulation parameter, buttons 50 and 52 may also controlpatient feedback input. When either of buttons 50 and 52 is selected,patient programmer 30 may initialize communication with IMD 14 or 26 tochange therapy accordingly.

When depressed by patient 12, stimulation ON button 54 directsprogrammer 30 to generate a command for communication to IMD 14 thatturns on stimulation therapy. Stimulation OFF button 56 turns offstimulation therapy when depressed by patient 12. Sync button 58 forcespatient programmer 30 to communicate with IMD 14. When patient 12 entersan automatic posture response screen of the user interface, pressingsync button 58 turns on the automatic posture response to allow IMD 14to automatically change therapy according to the posture state ofpatient 12. Pressing sync button 58 again, when the automatic postureresponse screen is displayed, turns off the automatic posture response.In the example of FIG. 2, patient 12 may use control pad 40 to adjustthe volume, contrast, illumination, time, and measurement units ofpatient programmer 30.

In some embodiments, buttons 54 and 56 may be configured to performoperational functions related to stimulation therapy or the use ofpatient programmer 30. For example, buttons 54 and 56 may control thevolume of audible sounds produced by programmer 20, wherein button 54increases the volume and button 56 decreases the volume. Button 58 maybe pressed to enter an operational menu that allows patient 12 toconfigure the user interface of patient programmer 30 to the desires ofpatient 12. For example, patient 12 may be able to select a language,backlight delay time, display 36 brightness and contrast, or othersimilar options. In alternative embodiments, buttons 50 and 52 maycontrol all operational and selection functions, such as those relatedto audio volume or stimulation therapy.

Patient programmer 30 may take other shapes or sizes not describedherein. For example, patient programmer 30 may take the form of aclam-shell shape, similar to some cellular phone designs. When patientprogrammer 30 is closed, some or all elements of the user interface maybe protected within the programmer. When patient programmer 30 isopened, one side of the programmer may contain a display while the otherside may contain input mechanisms. In any shape, patient programmer 30may be capable of performing the requirements described herein.Alternative embodiments of patient programmer 30 may include other inputmechanisms such as a keypad, microphone, camera lens, or any other mediainput that allows the user to interact with the user interface providedby patient programmer 30.

In alternative embodiments, the buttons of patient programmer 30 mayperform different functions than the functions provided in FIG. 2 as anexample. In addition, other embodiments of patient programmer 30 mayinclude different button layouts or different numbers of buttons. Forexample, patient programmer 30 may even include a single touch screenthat incorporates all user interface functionality with a limited set ofbuttons or no other buttons.

FIG. 3 is a conceptual diagram illustrating an example clinicianprogrammer 60 for programming stimulation therapy delivered by animplantable medical device. Clinician programmer 60 is an exampleembodiment of external programmer 20 illustrated in FIGS. 1A, 1B and 1Cand may be used with either IMD 14 or IMD 26. In alternativeembodiments, clinician programmer 60 may be used with an externalmedical device. As shown in FIG. 3, clinician programmer 60 provides auser interface (not shown) for a user, such as a clinician, physician,technician, or nurse, to manage and program stimulation therapy.Clinician programmer 60 is protected by housing 62, which enclosescircuitry necessary for clinician programmer 60 to operate.

Clinician programmer 60 includes display 64 and power button 66. In theexample of FIG. 3, display 64 is a touch screen that accepts user inputvia touching certain areas within display 64. The user may use stylus 68to touch display 64 and select virtual buttons, sliders, keypads, dials,or other such representations presented by the user interface shown bydisplay 64. In some embodiments, the user may be able to touch display64 with a finger, pen, or any other pointing device. In alternativeembodiments, clinician programmer 60 may include one or more buttons,keypads, control pads, touch pads, or other devices that accept userinput, similar to patient programmer 30.

In the illustrated embodiment, clinician programmer 60 is a hand helddevice. Clinician programmer 60 may be used within the clinic or onin-house patient calls. Clinician programmer 60 may be used tocommunicate with multiple IMDs 14 and 26 within different patients. Inthis manner, clinician programmer 60 may be capable of communicatingwith many different devices and retain patient data separate for otherpatient data. In some embodiments, clinician programmer 60 may be alarger device that may be less portable, such as a notebook computer,workstation, or even a remote computer that communicates with IMD 14 or26 via a remote telemetry device.

Most, if not all, of clinician programmer 60 functions may be completedvia the touch screen of display 64. The user may program stimulationtherapy, modify programs or groups, retrieve stored therapy data,retrieve posture state information, define posture states and otheractivity information, change the contrast and backlighting of display64, or any other therapy related function. In addition, clinicianprogrammer 60 may be capable of communicating with a networked server inorder to send or receive an email or other message, retrieve programminginstructions, access a help guide, send an error message, or perform anyother function that may be beneficial to prompt therapy.

Housing 62 may be constructed of a polymer, metal alloy, composite, orcombination material suitable to protect and contain components ofclinician programmer 60. In addition, housing 62 may be partially orcompletely sealed such that fluids, gases, or other elements may notpenetrate the housing and affect components therein. Power button 66 mayturn clinician programmer 60 ON or OFF as desired by the user. Clinicianprogrammer 60 may require a password, biometric input, or other securitymeasure to be entered and accepted before the user can use clinicianprogrammer 60.

Clinician programmer 60 may take other shapes or sizes not describedherein. For example, clinician programmer 60 may take the form of aclam-shell shape, similar to some cellular phone designs. When clinicianprogrammer 60 is closed, at least a portion of display 64 is protectedwithin housing 62. When clinician programmer 60 is opened, one side ofthe programmer may contain a display while the other side may containinput mechanisms. In any shape, clinician programmer 60 may be capableof performing the requirements described herein.

FIG. 4 is a functional block diagram illustrating various components ofan IMD 14. In the example of FIG. 4, IMD 14 includes a processor 80,memory 82, stimulation generator 84, posture state module 86, telemetrycircuit 88, and power source 90. Memory 82 may store instructions forexecution by processor 80, stimulation therapy data, posture stateinformation, posture state indications, and any other informationregarding therapy or patient 12. Therapy information may be recorded forlong-term storage and retrieval by a user, and the therapy informationmay include any data created by or stored in IMD 14. Memory 82 mayinclude separate memories for storing instructions, posture stateinformation, program histories, and any other data that may benefit fromseparate physical memory modules.

Processor 80 controls stimulation generator 84 to deliver electricalstimulation via electrode combinations formed by electrodes in one ormore electrode arrays. For example, stimulation generator 84 may deliverelectrical stimulation therapy via electrodes on one or more leads 16,e.g., as stimulation pulses or continuous waveforms. Componentsdescribed as processors within IMD 14, external programmer 20 or anyother device described in this disclosure may each comprise one or moreprocessors, such as one or more microprocessors, digital signalprocessors (DSPs), application specific integrated circuits (ASICs),field programmable gate arrays (FPGAs), programmable logic circuitry, orthe like, either alone or in any suitable combination.

Stimulation generator 84 may include stimulation generation circuitry togenerate stimulation pulses or waveforms and switching circuitry toswitch the stimulation across different electrode combinations, e.g., inresponse to control by processor 80. In particular, processor 80 maycontrol the switching circuitry on a selective basis to causestimulation generator 84 to deliver electrical stimulation to selectedelectrode combinations and to shift the electrical stimulation todifferent electrode combinations in a first direction or a seconddirection when the therapy must be delivered to a different locationwithin patient 12. In other embodiments, stimulation generator 84 mayinclude multiple current or voltage sources to drive more than oneelectrode combination at one time. In this case, stimulation generator84 may decrease a stimulation amplitude (e.g., a current or voltageamplitude) to the first electrode combination and simultaneouslyincrease a stimulation amplitude to the second electrode combination toshift the stimulation therapy.

An electrode combination may be represented by a data stored in a memorylocation, e.g., in memory 82, of IMD 14. Processor 80 may access thememory location to determine the electrode combination and controlstimulation generator 84 to deliver electrical stimulation via theindicated electrode combination. To change electrode combinations,amplitudes, pulse rates, or pulse widths, processor 80 may commandstimulation generator 84 to make the appropriate changes to therapyaccording to instructions within memory 82 and rewrite the memorylocation to indicate the changed therapy. In other embodiments, ratherthan rewriting a single memory location, processor 80 may make use oftwo or more memory locations.

When activating stimulation, processor 80 may access not only the memorylocation specifying the electrode combination but also other memorylocations specifying various stimulation parameters such as voltage orcurrent amplitude, pulse width and pulse rate. Stimulation generator 84,e.g., under control of processor 80, then makes use of the electrodecombination and parameters in formulating and delivering the electricalstimulation to patient 12. Processor 80 also may control telemetrycircuit 88 to send and receive information to and from externalprogrammer 20. For example, telemetry circuit 88 may send information toand receive information from patient programmer 30. An exemplary rangeof electrical stimulation parameters likely to be effective in treatingchronic pain, e.g., when applied to spinal cord 18, are listed below.While stimulation pulses are described, stimulation signals may be ofany of a variety of forms such as sine waves or the like.

1. Pulse Rate: between approximately 0.5 Hz and 1200 Hz, more preferablybetween approximately 5 Hz and 250 Hz, and still more preferably betweenapproximately 30 Hz and 130 Hz.

2. Amplitude: between approximately 0.1 volts and 50 volts, morepreferably between approximately 0.5 volts and 20 volts, and still morepreferably between approximately 1 volt and 10 volts. In otherembodiments, a current amplitude may be defined as the biological loadin the voltage that is delivered. For example, the range of currentamplitude may be between 0.1 milliamps (mA) and 50 mA.

3. Pulse Width: between about 10 microseconds and 5000 microseconds,more preferably between approximately 100 microseconds and 1000microseconds, and still more preferably between approximately 180microseconds and 450 microseconds.

In other applications, different ranges of parameter values may be used.For deep brain stimulation (DBS), as one example, alleviation orreduction of symptoms associated with Parkinson's disease, essentialtremor, epilepsy or other disorders may make use of stimulation having apulse rate in the range of approximately 0.5 to 1200 Hz, more preferably5 to 250 Hz, and still more preferably 30 to 185 Hz, and a pulse widthin the range of approximately 10 microseconds and 5000 microseconds,more preferably between approximately 60 microseconds and 1000microseconds, still more preferably between approximately 60microseconds and 450 microseconds, and even more preferably betweenapproximately 60 microseconds and 150 microseconds. Amplitude rangessuch as those described above with reference to SCS, or other amplituderanges, may be used for different DBS applications.

Processor 80 stores stimulation parameters in memory 82, e.g., asprograms and groups of programs. Upon selection of a particular programgroup, processor 80 may control stimulation generator 84 to deliverstimulation according to the programs in the groups, e.g.,simultaneously or on a time-interleaved basis. A group may include asingle program or multiple programs. As mentioned previously, eachprogram may specify a set of stimulation parameters, such as amplitude,pulse width and pulse rate. In addition, each program may specify aparticular electrode combination for delivery of stimulation. Again, theelectrode combination may specify particular electrodes in a singlearray or multiple arrays, e.g., on a single lead or among multipleleads.

Posture state module 86 allows IMD 14 to sense the patient posturestate, e.g., posture, activity or any other static position or motion ofpatient 12. In the example of FIG. 4, posture state module 86 mayinclude one or more accelerometers, such as three-axis accelerometers,capable of detecting static orientation or vectors in three-dimensions.For example, posture state module 86 may include one or moremicro-electro-mechanical accelerometers. In other examples, posturestate module 86 may alternatively or additionally include one or moregyroscopes, pressure transducers or other sensors to sense the posturestate of patient 12. Posture state information generated by posturestate module 86 and processor 80 may correspond to an activity and/orposture undertaken by patient 12 or a gross level of physical activity,e.g., activity counts based on footfalls or the like.

In some embodiments, processor 80 processes the analog output of theposture state sensor in posture state module 86 to determine activityand/or posture data. For example, processor 80 or a processor of posturestate module 86 may process the raw signals provided by the posturestate sensor to determine activity counts. In some embodiments,processor 80 may process the signals provided by the posture statesensor to determine velocity of motion information along each axis.

In one example, each of the x, y, and z signals provided by the posturestate sensor has both a DC component and an AC component. The DCcomponents may describe the gravitational force exerted upon the sensorand may thereby be used to determine orientation of the sensor withinthe gravitational field of the earth. Assuming the orientation of thesensor is relatively fixed with respect to patient 12, the DC componentsof the x, y and z signals may be utilized to determine the patient'sorientation within the gravitational field, and hence to determine theposture of the patient.

The AC component of the x, y and z signals may yield information aboutpatient motion. In particular, the AC component of a signal may be usedto derive a value for an activity describing the patient's motion. Thisactivity may involve a level, direction of motion, or acceleration ofpatient 12.

One method for determining the activity is an activity count. Anactivity count may be used to indicate the activity or activity level ofpatient 12. For example, a signal processor may sum the magnitudes ofthe AC portion of an accelerometer signal for “N” consecutive samples.For instance, assuming sampling occurs as 25 Hz, “N” may be set to 25,so that count logic provides the sum of the samples that are obtained inone second. This sum may be referred to as an “activity count.”

The number “N” of consecutive samples may be selected by processor 80 ora processor of posture state module 86 based on the current posturestate, if desired. The activity count may be the activity portion of theposture state parameter value that may be added to the posture portion.The resulting posture state parameter value may then incorporate bothactivity and posture to generate an accurate indication of the motion ofpatient 12.

As another example, the activity portion of the posture state parametervalue may describe a direction of motion. This activity parameter may beassociated with a vector and an associated tolerance, which may be adistance from the vector. Another example of an activity parameterrelates to acceleration. A value quantifying a level of change of motionover time in a particular direction may be associated with the activityportion of a posture state parameter value.

Posture state information from posture state module 86 may be stored inmemory 82 for later review by a clinician, used to adjust therapy,present a posture state indication to patient 12, or some combinationthereof. As an example, processor 80 may record the posture stateparameter value, or output, of the 3-axis accelerometer and assign theposture state parameter value to a certain predefined posture indicatedby the posture state parameter value. In this manner, IMD 14 may be ableto track how often patient 12 remains within a certain posture.

IMD 14 may also store which group or program was being used to delivertherapy when patient 12 was in the sensed posture. Further, processor 80may also adjust therapy for a new posture when posture state module 86indicates that patient 12 has in fact changed postures. Therefore, IMD14 may be configured to provide posture responsive stimulation therapyto patient 12. Stimulation adjustments in response to posture state maybe automatic or semi-automatic (subject to patient approval). In manycases, fully automatic adjustments may be desirable so that IMD 14 mayreact more quickly to posture state changes.

A posture state parameter value from posture state module 86 thatindicates the posture state may constantly vary throughout the day ofpatient 12. However, a certain activity (e.g., walking, running, orbiking) or a posture (e.g., standing, sitting, or lying down) mayinclude multiple posture state parameter values from posture statemodule 86. Memory 82 may include definitions for each posture state ofpatient 12. In one example, the definitions of each posture state may beillustrated as a cone in three-dimensional space. Whenever the posturestate parameter value, e.g., a vector, from the three-axis accelerometerof posture state module 86 resides within a predefined cone, processor80 indicates that patient 12 is in the posture state of the cone. A coneis described for purposes of example. Other definitions of posturestates may be illustrated as other shapes, e.g., donuts, inthree-dimensional space. In other examples, posture state parametervalue from the 3-axis accelerometer may be compared to a look-up tableor equation to determine the posture state in which patient 12 currentlyresides.

Posture responsive stimulation may allow IMD 14 to implement a certainlevel of automation in therapy adjustments. Automatically adjustingstimulation may free patient 12 from the constant task of manuallyadjusting therapy each time patient 12 changes posture or starts andstops a certain posture state. Such manual adjustment of stimulationparameters can be tedious, requiring patient 12 to, for example, depressone or more keys of patient programmer 30 multiple times during thepatient posture state to maintain adequate symptom control. In someembodiments, patient 12 may eventually be able to enjoy posture stateresponsive stimulation therapy without the need to continue makingchanges for different postures via patient programmer 30. Instead,patient 12 may transition immediately or over time to fully automaticadjustments based on posture state.

Although posture state module 86 is described as containing a 3-axisaccelerometer, posture state module 86 may contain multiple single-axisaccelerometers, dual-axis accelerometers, 3-axis accelerometers, or somecombination thereof. In some examples, an accelerometer or other sensormay be located within or on IMD 14, on one of leads 16 (e.g., at thedistal tip or at an intermediate position), an additional sensor leadpositioned somewhere within patient 12, within an independentimplantable sensor, or even worn on patient 12. For example, one or moremicrosensors may be implanted within patient 12 to communicate posturestate information wirelessly to IMD 14. In this manner, the patient 12posture state may be determined from multiple posture state sensorsplaced at various locations on or within the body of patient 12.

In other embodiments, posture state module 86 may additionally oralternatively be configured to sense one or more physiologicalparameters of patient 12. For example, physiological parameters mayinclude heart rate, electromyography (EMG), an electroencephalogram(EEG), an electrocardiogram (ECG), temperature, respiration rate, or pH.These physiological parameters may be used by processor 80, in someembodiments, to confirm or reject changes in sensed posture state thatmay result from vibration, patient travel (e.g., in an aircraft, car ortrain), or some other false positive of posture state.

Wireless telemetry in IMD 14 with external programmer 20, e.g., patientprogrammer 30 or clinician programmer 60, or another device may beaccomplished by radio frequency (RF) communication or proximal inductiveinteraction of IMD 14 with external programmer 20. Telemetry circuit 88may send information to and receive information from external programmer20 on a continuous basis, at periodic intervals, at non-periodicintervals, or upon request from the stimulator or programmer. To supportRF communication, telemetry circuit 88 may include appropriateelectronic components, such as amplifiers, filters, mixers, encoders,decoders, and the like.

Power source 90 delivers operating power to the components of IMD 14.Power source 90 may include a small rechargeable or non-rechargeablebattery and a power generation circuit to produce the operating power.Recharging may be accomplished through proximal inductive interactionbetween an external charger and an inductive charging coil within IMD14. As one example, external programmer 20 may include the charger torecharge power source 90 of IMD 14. Hence, the programmer and chargermay be integrated in the same device. Alternatively, in some cases, acharger unit may serve as an intermediate device that communicates withboth the IMD and the programmer. In some embodiments, power requirementsmay be small enough to allow IMD 14 to utilize patient motion andimplement a kinetic energy-scavenging device to trickle charge arechargeable battery. In other embodiments, traditional batteries may beused for a limited period of time. As a further alternative, an externalinductive power supply could transcutaneously power IMD 14 when neededor desired.

FIG. 5 is a functional block diagram illustrating various components ofan IMD 26 that is a drug pump. IMD 26 is a drug pump that operatessubstantially similar to IMD 14 of FIG. 4. IMD 26 includes processor 92,memory 94, pump module 96, posture state module 98, telemetry circuit100, and power source 102. Instead of stimulation generator 84 of IMD14, IMD 26 includes pump module 96 for delivering drugs or some othertherapeutic agent via catheter 28. Pump module 96 may include areservoir to hold the drug and a pump mechanism to force drug out ofcatheter 28 and into patient 12.

Processor 92 may control pump module 96 according to therapyinstructions stored within memory 94. For example, memory 94 may containthe programs or groups of programs that define the drug delivery therapyfor patient 12. A program may indicate the bolus size or flow rate ofthe drug, and processor 92 may accordingly deliver therapy. Processor 92may also use posture state information from posture state module 98 toadjust drug delivery therapy when patient 12 changes posture states,e.g., adjusts his (or her) posture.

FIG. 6 is a functional block diagram illustrating various components ofan external programmer 20 for IMD 14 or 26. As shown in FIG. 6, externalprogrammer 20 includes processor 104, memory 108, telemetry circuit 110,user interface 106, and power source 112. External programmer 20 may beembodied as patient programmer 30 or clinician programmer 60. Aclinician or patient 12 interacts with user interface 106 in order tomanually change the stimulation parameters of a program, change programswithin a group, turn posture responsive therapy ON or OFF, view therapyinformation, view posture state information, or otherwise communicatewith IMD 14 or 26.

User interface 106 may include a screen and one or more input buttons,as in the example of patient programmer 30, that allow externalprogrammer 20 to receive input from a user. Alternatively, userinterface 106 may additionally or only utilize a touch screen display,as in the example of clinician programmer 60. The screen may be a liquidcrystal display (LCD), dot matrix display, organic light-emitting diode(OLED) display, touch screen, or any other device capable of deliveringand/or accepting information. For visible posture state indications, adisplay screen may suffice. For audible and/or tactile posture stateindications, programmer 20 may further include one or more audiospeakers, voice synthesizer chips, piezoelectric buzzers, or the like.

Input buttons for user interface 106 may include a touch pad, increaseand decrease buttons, emergency shut off button, and other buttonsneeded to control the stimulation therapy, as described above withregard to patient programmer 30. Processor 104 controls user interface106, retrieves data from memory 108 and stores data within memory 108.Processor 104 also controls the transmission of data through telemetrycircuit 110 to IMD 14 or 26. Memory 108 includes operation instructionsfor processor 104 and data related to patient 12 therapy.

Telemetry circuit 110 allows the transfer of data to and from IMD 14, orIMD 26. Telemetry circuit 110 may communicate automatically with IMD 14at a scheduled time or when the telemetry circuit detects the proximityof the stimulator. Alternatively, telemetry circuit 110 may communicatewith IMD 14 when signaled by a user through user interface 106. Tosupport RF communication, telemetry circuit 110 may include appropriateelectronic components, such as amplifiers, filters, mixers, encoders,decoders, and the like. Power source 112 may be a rechargeable battery,such as a lithium ion or nickel metal hydride battery. Otherrechargeable or conventional batteries may also be used. In some cases,external programmer 20 may be used when coupled to an alternatingcurrent (AC) outlet, i.e., AC line power, either directly or via anAC/DC adapter.

FIG. 7 is a block diagram illustrating an example system 120 thatincludes an external device, such as a server 122, and one or morecomputing devices 124A-124N, that are coupled to IMD 14 and externalprogrammer 20 shown in FIGS. 1A-1C via a network 126. In this example,IMD 14 may use its telemetry circuit 88 to communicate with externalprogrammer 20 via a first wireless connection, and to communicate withan access point 128 via a second wireless connection. In other examples,IMD 26 may also be used in place of IMD 14, and external programmer 20may be either patient programmer 30 or clinician programmer 60.

In the example of FIG. 7, access point 128, external programmer 20,server 122, and computing devices 124A-124N are interconnected, and ableto communicate with each other, through network 126. In some cases, oneor more of access point 128, external programmer 20, server 122, andcomputing devices 124A-124N may be coupled to network 126 through one ormore wireless connections. IMD 14, external programmer 20, server 122,and computing devices 124A-124N may each comprise one or moreprocessors, such as one or more microprocessors, digital signalprocessors (DSPs), application specific integrated circuits (ASICs),field programmable gate arrays (FPGAs), programmable logic circuitry, orthe like, that may perform various functions and operations, such asthose described in this disclosure.

Access point 128 may comprise a device, such as a home monitoringdevice, that connects to network 126 via any of a variety ofconnections, such as telephone dial-up, digital subscriber line (DSL),or cable modem connections. In other embodiments, access point 128 maybe coupled to network 126 through different forms of connections,including wired or wireless connections.

During operation, IMD 14 may collect and store various forms of data.For example, IMD 14 may collect sensed posture state information duringtherapy delivery that indicate how patient 12 moves throughout each day.In some cases, IMD 14 may directly analyze the collected data toevaluate the patient 12 posture state, such as what percentage of timepatient 12 was in each identified posture state. In other cases,however, IMD 14 may send stored data relating to posture stateinformation to external programmer 20 and/or server 122, eitherwirelessly or via access point 128 and network 126, for remoteprocessing and analysis. For example, IMD 14 may sense, process, trendand evaluate the sensed posture state information. Alternatively,processing, trending and evaluation functions may be distributed toother devices such as external programmer 20 or server 122, which arecoupled to network 126. In addition, posture state information may bearchived by any of such devices, e.g., for later retrieval and analysisby a clinician.

In some cases, IMD 14, external programmer 20 or server 122 may processposture state information or raw data and/or therapy information into adisplayable posture state report, which may be displayed via externalprogrammer 20 or one of computing devices 124A-124N. The posture statereport may contain trend data for evaluation by a clinician, e.g., byvisual inspection of graphic data. In some cases, the posture statereport may include the number of activities patient 12 conducted, apercentage of time patient 12 was in each posture state, the averagetime patient 12 was continuously within a posture state, what group orprogram was being used to deliver therapy during each activity, thenumber of adjustments to therapy during each respective posture state,or any other information relevant to patient 12 therapy, based onanalysis and evaluation performed automatically by IMD 14, externalprogrammer 20 or server 122. A clinician or other trained professionalmay review and/or annotate the posture state report, and possiblyidentify any problems or issues with the therapy that should beaddressed.

In some cases, server 122 may be configured to provide a secure storagesite for archival of posture state information that has been collectedfrom IMD 14 and/or external programmer 20. Network 126 may comprise alocal area network, wide area network, or global network, such as theInternet. In some cases, external programmer 20 or server 122 mayassemble posture state information in web pages or other documents forviewing by trained professionals, such as clinicians, via viewingterminals associated with computing devices 124A-124N. System 120 may beimplemented, in some aspects, with general network technology andfunctionality similar to that provided by the Medtronic CareLink®Network developed by Medtronic, Inc., of Minneapolis, Minn.

Although some examples of the disclosure may involve posture stateinformation and data, system 120 may be employed to distribute anyinformation relating to the treatment of patient 12 and the operation ofany device associated therewith. For example, system 120 may allowtherapy errors or device errors to be immediately reported to theclinician. In addition, system 120 may allow the clinician to remotelyintervene in the therapy and reprogram IMD 14, patient programmer 30, orcommunicate with patient 12. In an additional example, the clinician mayutilize system 120 to monitor multiple patients and share data withother clinicians in an effort to coordinate rapid evolution of effectivetreatment of patients.

Furthermore, although the disclosure is described with respect to SCStherapy, such techniques may be applicable to IMDs that convey othertherapies in which posture state information is important, such as,e.g., DBS, pelvic floor stimulation, gastric stimulation, occipitalstimulation, functional electrical stimulation, and the like. Also, insome aspects, techniques for evaluating posture state information, asdescribed in this disclosure, may be applied to IMDs that are generallydedicated to sensing or monitoring and do not include stimulation orother therapy components.

FIGS. 8A-8C are conceptual illustrations of posture state spaces 140,152, 155 within which posture state reference data may define theposture state of patient 12. Posture state reference data may definecertain regions associated with particular posture states of patient 12within the respective posture state spaces 140, 152, 155. The output ofone or more posture state sensors may be analyzed by posture statemodule 86 with respect to posture state spaces 140, 152, 155 todetermine the posture state of patient 12. For example, if the output ofone or more posture state sensors is within a particular posture regiondefined by posture state reference data, posture state module 86 maydetermine that patient 12 is within the posture state associated withthe respective posture state region.

In some cases, one or more posture state regions may be defined asposture state cones. Posture state cones may be used to define a posturestate of patient 12 based on the output from a posture state sensor of aposture state according to an example method for posture statedetection. A posture state cone may be centered about a posture statereference coordinate vector that corresponds to a particular posturestate. In the examples of FIGS. 8A and 8B, the posture state module 86of IMD 14 or IMD 26 may use a posture state sensor, e.g., a three-axisaccelerometer that provides data indicating the posture state of patient12, to sense posture vectors. While the sensed data may be indicative ofany posture state, postures of patient 12 will generally be used belowto illustrate the concept of posture cones. As shown in FIG. 8A, posturestate space 140 represents a vertical plane dividing patient 12 fromleft and right sides, or the sagittal plane. A posture state parametervalue from two axes of the posture state sensor may be used to determinethe current posture state of patient 12 according to the posture statespace 140. The posture state data may include x, y and z coordinatevalues.

A posture cone may be defined by a reference coordinate vector for agiven posture state in combination with a distance or angle defining arange of coordinate vectors within a cone surrounding the posturereference coordinate vector. Alternatively, a posture cone may bedefined by a reference coordinate vector and a range of cosine valuescomputed using the reference coordinate vector as an adjacent vector andany of the outermost vectors of the cone as a hypotenuse vector. If asensed posture state vector is within an applicable angle or distance ofthe reference coordinate vector, or if the sensed posture state vectorand the reference coordinate vector produce a cosine value in aspecified cosine range, then posture state vector is determined toreside within the posture cone defined by the reference coordinatevector.

Posture state space 140 is segmented into different posture cones thatare indicative of a certain posture state of patient 12. In the exampleof FIG. 8A, upright cone 142 indicates that patient 12 is sitting orstanding upright, lying back cone 148 indicates that patient 12 is lyingback down, lying front cone 144 indicates that patient 12 is lying chestdown, and inverted cone 146 indicates that patient 12 is in an invertedposition. Other cones may be provided, e.g., to indicate that patient 12is lying on the right side or left side. For example, a lying rightposture cone and a lying left posture cone positioned outside of thesagittal plane illustrated in FIG. 8A. In particular, the lying rightand lying left posture cones may be positioned in a coronal planesubstantially perpendicular to the sagittal plane illustrated in FIG.8A. For ease of illustration, lying right and lying left cones are notshown in FIG. 8A.

Vertical axis 141 and horizontal axis 143 are provided for orientationof posture state area 140, and are shown as orthogonal for purposes ofillustration. However, posture cones may have respective posturereference coordinate vectors that are not orthogonal in some cases. Forexample, individual reference coordinate vectors for cones 142 and 146may not share the same axis, and reference coordinate vectors for cones144 and 148 may not share the same axis. Also, reference coordinatevectors for cones 144 and 148 may or may not be orthogonal to referencecoordinates vectors for cones 142, 146. Therefore, although orthogonalaxes are shown in FIG. 8A for purposes of illustration, respectiveposture cones may be defined by individualized reference coordinatevectors for the cones.

IMD 14 may monitor the posture state parameter value of the posturestate sensor to produce a sensed coordinate vector and identify thecurrent posture of patient 12 by identifying which cone the sensedcoordinated vector of the posture state sensor module 86 resides. Forexample, if the posture state parameter value corresponds to a sensedcoordinate vector that falls within lying front cone 144, IMD 14determines that patient 12 is lying down on their chest. IMD 14 maystore this posture information as a determined posture state or as rawoutput from the posture state sensor, change therapy according to theposture, or both. Additionally, IMD 14 may communicate the postureinformation to patient programmer 30 so that the patient programmer canpresent a posture state indication to patient 12.

In addition, posture state area 140 may include hysteresis zones 150A,150B, 150C, and 150D (collectively “hysteresis zones 150”). Hysteresiszones 150 are positions within posture state area 140 where no posturecones have been defined. Hysteresis zones 150 may be particularly usefulwhen IMD 14 utilizes the posture state information and posture cones toadjust therapy automatically. If the posture state sensor indicates thatpatient 12 is in upright cone 142, IMD 14 would not detect that patient12 has entered a new posture cone until the posture state parametervalue indicates a different posture cone. For example, if IMD 14determines that patient 12 moves to within hysteresis zone 150A fromupright cone 142, IMD 14 retains the posture as upright. In this manner,IMD 14 does not change the corresponding therapy until patient 12 fullyenters a different posture cone. Hysteresis zones 150 prevent IMD 14from continually oscillating between different therapies when patient12's posture state resides near a posture cone boundary.

Each posture cone 142, 144, 146, 148 may be defined by an angle inrelation to a reference coordinate vector defined for the respectiveposture cone. Alternatively, some posture cones may be defined by anangle relative to a reference coordinate vector for another posturecone. For example, lying postures may be defined by an angle withrespect to a reference coordinate vector for an upright posture cone. Ineach case, as described in further detail below, each posture cone maybe defined by an angle in relation to a reference coordinate posturevector defined for a particular posture state. The reference coordinatevector may be defined based on posture sensor data generated by aposture state sensor while patient 12 occupies a particular posturestate desired to be defined using the reference coordinate vector. Forexample, a patient may be asked to occupy a posture so that a referencecoordinate vector can be sensed for the respective posture. In thismanner, vertical axis 141 may be specified according to the patient'sactual orientation. Then, a posture cone can be defined using thereference coordinate vector as the center of the cone.

Vertical axis 141 in FIG. 8A may correspond to a reference coordinatevector sensed while the patient was occupying an upright posture state.Similarly, a horizontal axis 143 may correspond to a referencecoordinate vector sensed while the patient is occupying a lying posturestate. A posture cone may be defined with respect to the referencecoordinate vector. Although a single axis is shown extending through theupright and inverted cones 142, 146, and another single axis is shownextending through the lying down and lying up cones 144, 148, individualreference coordinate vectors may be used for respective cones, and thereference coordinate vectors may not share the same axes, depending ondifferences between the reference coordinate vectors obtained for theposture cones.

Posture cones may be defined by the same angle or different angles,symmetrical to either axis, or asymmetrical to either axis. For example,upright cone 142 may have an angle of eighty degrees, +40 degrees to −40degrees from the positive vertical axis 141. In some cases, lying conesmay be defined relative to the reference coordinate vector of theupright cone 142. For example, lying up cone 148 may have an angle ofeighty degrees, −50 degrees to −130 degrees from the positive verticalaxis 141. Inverted cone 146 may have an angle of eighty degrees, −140degrees to +140 degrees from vertical axis 141. In addition, lying downcone 144 may have an angle of eighty degrees, +50 degrees to +130degrees from the positive vertical axis 141. In other examples, eachposture cone may have varying angle definitions, and the angles maychange during therapy delivery to achieve the most effective therapy forpatient 12.

Alternatively, or additionally, instead of an angle, posture cones 144,146, 148, 148 may be defined by a cosine value or range of cosine valuesin relation to vertical axis 141, horizontal axis 143, or some otheraxis, such as, e.g., individual reference coordinate vectors for therespective cones. For example, a posture cone may be defined by a cosinevalue that defines the minimum cosine value, calculated using areference coordinate vector and a respective coordinate vector sensed bya posture state sensor at any point in time. In the cosine computation,the value (adjacent/hypotenuse) can be computed using the magnitude ofthe coordinate reference vector as the adjacent and a vector at theoutermost extent of the cone as the hypotenuse to define a range ofcosine values consistent with the outer bound of the cone.

For upright cone 142, the cosine range may extend from the maximumcosine value of 1.0, corresponding to a sensed vector that matches thereference coordinate vector of the upright cone, to a minimum cosinevalue that corresponds to a sensed vector at the outer limit of theupright cone. As another example, for lying cone 144, the cosine rangemay extend from the maximum cosine value of 1.0, corresponding to asensed vector that matches the reference coordinate vector of the lyingcone, to a minimum cosine value that corresponds to a sensed vector atthe outer limit of the lying cone. Alternatively, the lying cone 144 maybe defined with reference to the upright cone 142, such that the cosinerange may extend between a maximum and minimum values determinedrelative to the reference coordinate vector for the upright cone.

In other examples, posture state area 140 may include additional posturecones than those shown in FIG. 8A. For example, a reclining cone may belocated between upright cone 142 and lying back cone 148 to indicatewhen patient 12 is reclining back (e.g., in a dorsal direction). In thisposition, patient 12 may need a different therapy to effectively treatsymptoms. Different therapy programs may provide efficacious therapy topatient 12 when patient 12 is in each of an upright posture (e.g.,within upright cone 142), lying back posture (e.g., within lying backcone 148), and a reclining back posture. Thus, a posture cone thatdefines the reclining back posture may be useful for providingefficacious posture-responsive therapy to patient 12. In other examples,posture state area 140 may include fewer posture cones than cones 142,144, 146, 148 shown in FIG. 8A. For example, inverted cone 146 may bereplaced by a larger lying back cone 148 and lying front cone 144.

FIG. 8B illustrates an example posture state space 152 that is athree-dimensional space in which the posture state parameter value fromthe posture state sensor is placed in relation to the posture cones.Posture state space 152 is substantially similar to posture state area140 of FIG. 8A. However, the posture state parameter value derived fromall three axes of a 3-axis accelerometer may be used to accuratelydetermine the posture state of patient 12. In the example of FIG. 8B,posture state space 152 includes upright cone 154, lying back cone 156,and lying front cone 158. Posture state space 152 also includeshysteresis zones (not shown) similar to those of posture state area 140.In the example of FIG. 8B, the hysteresis zones are the spaces notoccupied by a posture cone, e.g., upright cone 154, lying back cone 156,and lying front cone 158.

Posture cones 154, 156 and 158 also are defined by a respective centerline 153A, 153B, or 153C, and associated cone angle A, B or C. Forexample, upright cone 154 is defined by center line 153A that runsthrough the center of upright cone 154. Center line 153A may correspondto an axis of the posture state sensor or some other calibrated vector.In some embodiments, each center line 153A, 153B, 153C may correspond toa posture reference coordinate vectors defined for the respectivepostures, e.g., the upright posture. For instance, assuming that patient12 is standing, the DC portion of the x, y, and z signals detected bythe posture state sensor of posture state module 86 define a posturevector that corresponds to center line 153A.

The x, y, and z signals may be measured while patient 12 is known to bein a specified position, e.g., standing, and the measured vector may becorrelated with the upright posture state. Thereafter, when the DCportions of the posture state sensor signal are within somepredetermined cone tolerance or proximity, e.g., as defined by an angle,distance or cosine value, of the posture reference coordinate vector(i.e., center line 153A), it may be determined that patient 12 is in theupright posture. In this manner, a sensed posture coordinate vector maybe initially measured based on the output of one or more posture statesensors of posture state module 86, associated with a posture state,such as upright, as a reference coordinate vector, and then later usedto detect a patient's posture state.

As previously indicated, it may be desirable to allow some tolerance tobe associated with a defined posture state, thereby defining a posturecone or other volume. For instance, in regard to the upright posturestate, it may be desirable to determine that a patient who is uprightbut leaning slightly is still in the same upright posture state. Thus,the definition of a posture state may generally include not only aposture reference coordinate vector (e.g., center line 153A), but also aspecified tolerance. One way to specify a tolerance is by providing anangle, such as cone angle A, relative to coordinate reference vector153A, which results in posture cone 154 as described herein. Cone angleA is the deflection angle, or radius, of upright cone 154. The totalangle that each posture cone spans is double the cone angle. The coneangles A, B, and C may be generally between approximately 1 degree andapproximately 70 degrees. In other examples, cone angles A, B, and C maybe between approximately 10 degrees and 30 degrees. In the example ofFIG. 8B, cone angles A, B, and C are approximately 20 degrees. Coneangles A, B, and C may be different, and center lines 153A, 153B, and153C may not be orthogonal to each other.

In some examples, a tolerance may be specified by a cosine value orrange of cosine values. The use of cosine values, in some cases, mayprovide substantial processing efficiencies. As described above, forexample, a minimum cosine value, determined using the referencecoordinate vector as adjacent and sensed coordinate vector ashypotenuse, indicates the range of vectors inside the cone. If a sensedcoordinate vector, in conjunction with the reference coordinate vectorfor a posture cone, produces a cosine value that is less than theminimum cosine value for the posture cone, the sensed coordinate vectordoes not reside within the pertinent posture cone. In this manner, theminimum cosine value may define the outer bound of a range of cosinevalues within a particular posture cone defined in part by a referencecoordinate vector.

While center lines 153A, 153B, 153C of each of the posture cones 154,156, 158, respectively, are shown in FIG. 8B as being substantiallyorthogonal to each other, in other examples, center lines 153A, 153B,and 153C may not be orthogonal to each other. Again, the relativeorientation of center lines 153A, 153B, 153C may depend on the actualreference coordinate vector output of the posture state sensor ofposture state module 86 of IMD 14 when patient 12 occupies therespective postures.

In some cases, all of the posture cones may be individually definedbased on actual reference coordinate vectors. Alternatively, in somecases, some posture cones may be defined with reference to one or morereference coordinate vectors for one or more other posture cones. Forexample, lying reference coordinate vectors could be assumed to beorthogonal to an upright reference coordinate vector. Alternatively,lying reference coordinate vectors could be individually determinedbased on sensed coordinate vectors when the patient is in respectivelying postures. Hence, the actual reference coordinate vectors fordifferent postures may be orthogonal or non-orthogonal with respect toone another.

In addition to upright cone 154, lying back cone 156, and lying frontcone 158, posture state space 152 may include additional posture cones.For example, a lying right cone may be provided to define a patientposture in which patient 12 is lying on his right side and a lying leftcone may be provided to define a patient posture in which patient 12 islying on his left side. In some cases, the lying right cone and lyingleft cone may be positioned approximately orthogonal to upright cones154, in approximately the same plane as lying back cone 156 and lyingfront cone 158. Moreover, posture state space 152 may include aninverted cone positioned approximately opposite of upright cone 154.Such a cone indicates that the patient's posture is inverted from theupright posture, i.e., upside down.

In some examples, to detect the posture state of a patient, posturestate module 86 of IMD 14 may determine a sensed coordinate vector basedon the posture sensor data generated by one or more posture statesensors, and then analyze the sensed coordinate vector with respect toposture cones 154, 156, 158 of FIG. 8B. For example, in a case in whicha posture cone is defined by a reference coordinate vector and atolerance angle, e.g., tolerance angle “A,” posture state module 86 maydetermine whether the sensed coordinate vector is within upright posturecone 154 by calculating the angle between the sensed coordinate vectorand reference coordinate vector, and then determine whether the angle isless than the tolerance angle “A.” If so, posture state module 86determines that the sensed coordinate vector is within upright posturecone 154 and detects that patient 12 is in the upright posture. Ifposture state module 86 determines that sensed coordinate vector is notwithin upright posture cone 154, posture state module 86 detects thatpatient 12 is not in the upright posture.

Posture state module 86 may analyze the sensed coordinate vector inposture state space 152 with respect to each individual defined posturecone, such as posture cones 156 and 158, in such a manner to determinethe posture state of patient 12. For example, posture state module 86may determine the angle between the sensed coordinate vector andreference coordinate vector of individual posture cones defined for theposture state, and compare the determined angle to the tolerance angledefined for the respective posture cone. In this manner, a sensedcoordinate vector may be evaluated against each posture cone until amatch is detected, i.e., until the sensed coordinate vector is found toreside in one of the posture cones. Hence, a cone-by-cone analysis isone option for posture detection.

In other examples, different posture detection analysis techniques maybe applied. For example, instead of testing a sensed coordinate vectoragainst posture cones on a cone-by-cone basis, a phased approach may beapplied where the sensed coordinate vector is classified as eitherupright or not upright. In this case, if the sensed coordinate vector isnot in the upright cone, posture state module 86 may determine whetherthe sensed coordinate vector is in a lying posture, either by testingthe sensed coordinate vector against individual lying posture cones ortesting the sensed coordinate vector against a generalized lying posturevolume, such as a donut- or toroid-like volume that includes all of thelying postures, and may be defined using an angle or cosine rangerelative to the upright vector, or relative to a modified or virtualupright vector as will be described. In some cases, if lying posturesare defined by cones, the lying volume could be defined as a logical ORof the donut- or toroid-like volume and the volumes of the lying posturecones. If the cones are larger such that some portions extend beyond thelying volume, then those portions can be added to the lying volume usingthe logical OR-like operation.

If the sensed coordinate vector resides within the donut- or toroid-likelying volume, then the sensed coordinate vector may be tested againsteach of a plurality of lying posture cones in the lying volume.Alternatively, the posture detection technique may not use lying cones.Instead, a posture detection technique may rely on a proximity testbetween the sensed coordinate vector and each of the referencecoordinate vectors for the respective lying postures. The proximity testmay rely on angle, cosine value or distance to determine which of thelying posture reference coordinate vectors is closest to the sensedcoordinate vector. For example, the reference coordinate vector thatproduces the largest cosine value with the sensed coordinate vector ashypotenuse and the reference coordinate vector as adjacent is theclosest reference coordinate vector. In this case, the lying postureassociated with the reference coordinate vector producing the largestcosine value is the detected posture. Hence, there are a variety of waysto detect posture, such as using posture cones, using an upright posturecone with lying volume and lying posture cone test, or using an uprightposture cone with lying volume and lying vector proximity test.

As a further illustration of an example posture detection technique,posture state module 86 may first determine whether patient 12 isgenerally in a lying posture state or upright posture state by analyzingthe sensed coordinate vector in posture state space 152 with respect toan axis 153A for the upright posture state. Axis 153A may correspond tothe upright reference coordinate vector. For example, angle “A” may beused to define upright posture cone 154, as described above, and angles“D” and “E” may be used to define the vector space in which patient 12may be generally considered to be in the lying posture state, regardlessof the particular posture state cone, e.g., lying front cone 158, lyingback cone 156, lying right cone (not shown), or lying left cone (notshown), in which the sensed coordinate vector falls.

If it is determined that a sensed coordinate vector is not within anangle A of the axis 153A, then it may be determined that the patient isnot in the upright posture indicated by the upright posture cone. Inthis case, it may next be determined whether a sensed coordinated vectoris generally in a lying posture space volume, which may be consideredsomewhat donut- or toroid-like, and may be defined relative to theupright reference coordinate vector 153A. As shown, angles “D” and “E”define the minimum and maximum angle values, respectively, that a sensedvector may form with respect to axis 153A of patient 12 for adetermination to be made that the patient is generally in the lyingposture state. Again, cosine values may be used instead of angles todetermine the positions of sensed coordinate vectors relative to posturecones or other posture volumes, or relative to reference coordinatevectors.

As illustrated, angles “D” and “E” may be defined with respect tovertical axis 153A (which may correspond to an upright referencecoordinate vector), which is the reference coordinate vector for theupright posture cone, rather than with respect to a reference coordinatevector of a lying posture state cone. If a sensed vector is within theangular range of D to E, relative to axis 153A, then it can bedetermined by posture state module 86 that the patient is generally in alying posture. Alternatively, in some examples, an angle C could bedefined according to a generally horizontal axis 153C (which maycorrespond to one of the lying reference coordinate vectors). In thiscase, if a sensed vector is within angle C of axis 153C, it can bedetermined by posture state module 86 that the patient is in a lyingposture. In each case, the region generally defining the lying posturestate may be referred to as a posture donut or posture toroid, ratherthan a posture cone. The posture donut may generally encompass a rangeof vectors that are considered to be representative of various lyingdown postures.

As an alternative, posture state module 86 may rely on cosine values ora range of cosine values to define the posture donut or toroid withrespect to axis 153A. When the sensed vector falls within the vectorspace defined by axis 153A and angles “D” and “E”, or produces a cosinevalue with the reference coordinate vector 153A in a prescribed range,posture state module 86 may determine that patient 12 is generally in alying posture state. For example, if the sensed vector and referencecoordinate vector 153 produce a cosine value in a first range, theposture is upright. If the cosine value is in a second range, theposture is lying. If the cosine value is outside of the first and secondranges, the posture may be indeterminate. The first range may correspondto the range of cosine values that would be produced by vectors inposture cone 154 defined by angle A, and the second range may becorrespond to cosine values that would be produced by vectors in theposture donut defined by angles D and E.

When the sensed vector fall within the vector space defined by axis 153Aand angles “D” and “E”, as indicated by angle or cosine value, posturestate module 86 may then determine the particular lying posture stateoccupied by patient 12, e.g., lying front, lying back, lying right, orlying left. To determine the particular lying posture state occupied bypatient 12, posture state module 86 may analyze the sensed vector withrespect to reference coordinate vectors for individual lying posturestate cones, e.g., lying front cone 156, lying back cone 158, lyingright cone (not shown), and lying left cone (not shown), using one moretechniques previously described, such as angle or cosine techniques. Forexample, posture state module 86 may determine whether the sensedcoordinated vector resides within one of the lying posture state conesand, if so, select the posture state corresponding to that cone as thedetected posture state.

FIG. 8C illustrates an example posture state space 155 that is athree-dimensional space substantially similar to posture state space 152of FIG. 8B. Posture state space 155 includes upright posture cone 157defined by reference coordinate vector 167. The tolerance that definesupright posture cone 157 with respect to reference coordinate vector 167may include a tolerance angle or cosine value, as described above. Incontrast to determining whether a sensed coordinate vector resides in alying cone, FIG. 8C illustrates a method for detecting a lying posturebased on proximity of a sensed coordinate vector to one of the referencecoordinate vectors for the lying postures.

As shown in FIG. 8C, posture state space 155 includes four referencecoordinate vectors 159, 161, 163, 165, which are associated with lyingleft, lying right, lying front, and lying back posture states,respectively. Posture state module 86 may have defined each of the fourreference coordinated vector 159, 161, 163, 165 based on the output ofone or more posture sensors while patient 12 occupied each of thecorresponding posture states. Unlike lying front and lying back posturecones 158, 156 in the example of FIG. 8B, the posture state referencedata for the four defined posture states corresponding to referencevectors 159, 161, 163, 165 need not include angles defined relative tothe respective reference vector in a manner that defines a posture cone.Rather, as will be described below, the respective posture statereference vectors may be analyzed with respect to one another in termsof cosine values to determine which particular reference coordinatevector is nearest in proximity to a sensed coordinate vector.

In some examples, to determine the posture state of patient 12, posturestate module 85 may determine whether a sensed coordinate vector iswithin upright posture cone 157 by analyzing the sensed coordinatevector in view of the tolerance angle or cosine value(s) defined withrespect to upright posture reference coordinate vector 167, or whetherthe sensed vector is within a posture donut or toroid defined by a rangeof angles (as in FIG. 8B) or cosine values with respect to uprightposture reference coordinate vector 167, in which case posture statemodule 86 may determine that patient 12 is in a general lying posturestate.

If posture state module 86 determines that patient 12 is occupying ageneral lying posture state, posture state module 86 may then calculatethe cosine value of the sensed coordinate vector with respect to eachlying reference coordinate vectors 159, 161, 163, 165. In such a case,posture state module 86 determines the particular lying posture state ofpatient 12, i.e., lying left, lying right, lying front, lying back,based on which cosine value is the greatest of the four cosine values.For example, if the cosine value calculated with the sensed vector asthe hypotenuse and the lying front reference vector 163 as the adjacentvector is the largest value of the four cosine values, the sensed vectormay be considered closest in proximity to lying front reference vectorout of the four total reference vectors 159, 161, 163, 165. Accordingly,posture state module 85 may determine that patient 12 is occupying alying front posture state.

In some examples, posture state module 86 may determine whether patient12 is generally in a lying posture state based on the relationship of asensed vector to upright reference vector 167. For example, as describedabove, a lying posture donut or toroid may be defined with respect toupright posture reference vector 167, e.g., using angles D and E as inFIG. 8B. Such a technique may be appropriate when lying posturereference vectors 159, 161, 163, 165 define a common plane substantiallyorthogonal to upright posture reference vector 167. However, the lyingposture reference vectors 159, 161, 163, 165 may not in fact beorthogonal to the upright reference coordinate vector 167. Also, thelying posture reference vectors 159, 161, 163, 165 may not reside in thesame plane.

To account for non-orthogonal reference vectors, in other examples, alying posture donut or toroid may be defined with respect to a modifiedor virtual upright reference vector 169 rather than that actual uprightposture reference vector 167. Again, such a technique may be used insituations in which the lying reference vectors 159, 161, 163, 165 arenot in a common plane, or the common plane of reference vector 159, 161,163, 165 is not substantially orthogonal to upright reference vector167. However, use of the example technique is not limited to suchsituations.

To define virtual upright reference vector 169, posture state module 86may compute the cross-products of various combinations of lyingreference vectors 159, 161, 163, 165 and average the cross productvalues. In the example of FIG. 8C, posture state module 86 may computefour cross products and average the four cross product vectors to yieldthe virtual upright vector. The cross product operations that may beperformed are: lying left vector 159×lying back vector 165, lying backvector 165×lying right vector 161, lying right vector 161×lying frontvector 163, and lying front vector 163×lying left vector 159. Each crossproduct yields a vector that is orthogonal to the two lying referencevectors that were crossed. Averaging each of the cross product vectorsyields a virtual upright reference vector that is orthogonal to lyingplane 171 approximately formed by lying reference vectors 159, 161, 163,165.

Using virtual upright reference vector 169, posture state module 86 maydefine a lying posture donut or toroid in a manner similar to thatdescribed with respect to upright reference vector 167, but instead withrespect to virtual upright reference vector 169. In particular, whenposture state module 86 determines that the patient is not in theupright posture, the posture state module determines whether the patientis in a lying posture based on an angle or cosine value with respect tothe virtual upright reference vector 169.

Posture state module 86 may still determine whether patient 12 is in anupright posture state using upright posture cone 157. If posture statemodule 86 determines that patient 12 is occupying a general lyingposture state based on the analysis of the sensed coordinate vector withrespect to virtual upright reference vector 169, posture state module 86may then calculate the cosine value of the sensed coordinate vector (ashypotenuse) with respect to each lying reference coordinate vectors 159,161, 163, 165 (as adjacent).

In such a case, posture state module 86 determines the particular lyingposture state of patient 12, i.e., lying left, lying right, lying front,lying back, based on which cosine value is the greatest of the fourcosine values. For example, if the cosine value calculated with thelying front reference vector 163 is the largest value of the four cosinevalues, the sensed vector may be considered closest in proximity tolying front reference vector out of the four total reference vectors159, 161, 163, 165. Accordingly, posture state module 85 may determinethat patient 12 is occupying a lying front posture state.

Additionally, posture state definitions are not limited to posturecones. For example, a definition of a posture state may involve aposture vector and a tolerance, such as a maximum distance from theposture vector. So long as a detected posture vector is within thismaximum distance from the posture vector that is included in thedefinition of the posture state, patient 12 may be classified as beingin that posture state. This alternative method may allow posture statesto be detected without calculating angles, as is exemplified above inthe discussion related to posture cones.

Further to the foregoing, posture states may be defined that arespecific to a particular patient's activities and/or profession. Forinstance, a bank teller may spend a significant portion of his workingday leaning forward at a particular angle. A patient-specific “LeaningForward” posture state including this angle may be defined. The coneangle or other tolerance value selected for this posture state may bespecific to the particular posture state definition for this patient. Inthis manner, the defined posture states may be tailored to a specificuser, and need not be “hard-coded” in the IMD.

In some examples, individual posture states may be linked together,thereby tying posture states to a common set of posture reference dataand a common set of therapy parameter values. This may, in effect, mergemultiple posture cones for purposes of posture state-based selection oftherapy parameter values. For example, all lying posture state cones(back, front, left, right) could be treated as one cone or adonut/toroid, e.g., using a technique the same as or similar to thatdescribed with respect to FIGS. 8B and 8C to define a donut, toroid orother volume. One program group or common set of therapy parametervalues may apply to all posture states in the same merged cone,according to the linking status of the posture states, as directed viaexternal programmer 20.

Merging posture cones or otherwise linking a plurality of posture statestogether may be useful for examples in which a common set of therapyparameter values provides efficacious therapy to patient 12 for theplurality of posture states. In such an example, linking a plurality ofposture states together may help decrease the power consumption requiredto provide posture-responsive therapy to patient 12 because thecomputation required to track patient posture states and provideresponsive therapy adjustments may be minimized when a plurality ofposture states are linked together.

Linking of posture states also may permit a therapy parameter valueadjustment in one posture state to be associated with multiple posturestates at the same time. For example, the same amplitude level for oneor more programs may be applied to all of the posture states in a linkedset of posture states. Alternatively, the lying down posture states mayall reside within a “donut” or toroid that would be used instead ofseparate comes 156 and 158, for example. The toroid may be divided intosectional segments that each correspond to different posture states,such as lying (back), lying (front), lying (right), lying (left) insteadof individual cones. In this case, different posture reference data andtherapy parameter values may be assigned to the different sectionalsegments of the toroid.

A clinician may orient one or more sensors of posture state module 86.For example, as prompted by clinician programmer 60, a clinician mayinstruct patient 12 to occupy a specified posture, e.g., standing, sothat posture state module 86 may sense a reference coordinate vector forthe respective posture. The clinician may provide an indication thatpatient 12 is in the specified posture, e.g., via clinician programmer60. In response to the indication from the clinician, a vector measuredby posture state module 86 may be stored, e.g., in memory 82 of IMD 14,as a reference coordinate vector. The clinician may repeat this processwith various specified postures, e.g., lying back or lying front andlying left or lying right. The orientation process may yield a set ofreference coordinate vectors. These posture state reference coordinatevectors may be associated with posture state definitions and used toclassify the posture of patient 12 within a posture state.

As described with respect to FIGS. 8A-8C, a posture state may be definedby a posture state reference coordinate vector and a tolerance, e.g.,angle, cosine, or distance value. Clinician programmer 60 may prompt theclinician to orientate one or more sensors of posture state module 86 toestablish values for one or more posture state reference coordinatevectors associated with posture state definitions. Once values for theposture state reference coordinate vectors associated with the posturestate definitions have been established, posture state module 86 isenabled to classify the posture state of patient 12 according to the setof posture state definitions. In this manner, the only user inputrequired to enable the set of posture state definitions for postureresponsive therapy may be the indications received during theorientation procedure. The values for the posture state referencecoordinate vectors established during the orientation process are inputinto the pre-established posture state definitions.

FIGS. 9-13 describe techniques for associating a therapy adjustment witha posture state based on user input. Since patient 12 may adjust therapyafter he (or she) moves to a new posture state or in anticipation ofmoving to a new posture state, observing the patient's posture statesafter the adjustment is made may help ensure that the adjusted therapyis associated with the intended posture state. For example, IMD 14 maydetermine that a therapy adjustment made by patient 12 to increase theamplitude of the current program is associated with the next posturestate assumed by patient 12, instead of the posture occupied before atransition to the next posture state. In some examples, IMD 14 may thenautomatically associate the therapy adjustment with the associatedposture state, e.g., if the adjusted therapy parameter was previouslyundefined for the posture state. In this case, the next time patient 12engages in the same posture state as the association, IMD 14 willdeliver stimulation therapy according to the increased amplitudespecified by patient 12 due to the association. Therefore, IMD 14 mayuse posture search timers and posture stability timers as described withrespect to FIGS. 9-13, to learn or update program therapy parameterssuch that IMD 14 remembers the therapy parameters for therapy deliveryfor subsequent delivery according to the engaged posture state. In otherexamples, IMD 14 may store therapy adjustments and corresponding therapyadjustments for purposes of evaluating therapy efficacy.

FIG. 9 is a conceptual diagram illustrating example posture search timer350 and posture stability timer 352 when patient 12 remains in oneposture state. IMD 14 must be able to correctly associate each therapyadjustment to a therapy parameter with the intended posture state ofpatient 12 when the therapy adjustment was made. For example, patient 12may make therapy adjustments to customize the therapy either afterpatient 12 moves to a different posture state or in anticipation of thenext posture state. IMD 14 may employ posture search timer 350 andposture stability timer 352 to track therapy adjustments and the currentposture state of patient 12.

Posture search timer 350 has a search period that is a set amount oftime from the time the therapy adjustment is made, when posture searchtimer 350 starts, to when the final posture state must have begun, priorto the expiration of the search period. In addition, posture stabilitytimer 352 has a stability period that is a set amount of time thatpatient 12 must remain within the final posture state for the therapyadjustment made to be associated with the final posture state. Posturestability timer 352 restarts at any time that patient 12 changes posturestates. Therefore, the search period and stability period must overlapfor the therapy adjustment to be associated with a posture state notcurrently engaged by patient 12 when the therapy adjustment was made.

In the example of FIG. 9, patient 12 made a therapy adjustment to one ofthe therapy parameters, such as voltage or current amplitude, at timeT₀. Therefore, posture search timer 350 starts at T₀ and runs for apredetermined search period until time T₁. When the therapy adjustmentis made, posture stability timer 352 also starts at time T₀ in thecurrent posture state of patient 12 and runs for the stability periodthat happens to be the same as the search period in this example. Sincepatient 12 has not changed to any different posture states between timesT₀ and T₁, the stability period also ends at T₁. The therapy adjustmentmade by patient 12 at time T₀ is associated with the posture statesensed between times T₀ and T₁ because both the search period andstability period overlap. In the example of FIG. 9, posture search timer350 and posture stability timer 352 may not be needed, but their purposemay become clearer in the following examples.

The search period of posture search timer 350 may be of any timeduration desired by a device manufacturer, and the clinician may or maynot be permitted to set the search period. Generally, the search periodmay be between approximately 30 seconds and 30 minutes, but it may beset to any time desired, including a time that is outside of that range.More specifically, the search period may be between approximately 30seconds and 5 minutes in order to provide a reasonable amount of timefor patient 12 to be situated in the final desired posture state. Morepreferably, the search period may be between approximately 2 minutes and3 minutes. In some examples, and as described in the examples of FIGS.9-13, the search period is approximately 3 minutes.

In addition, the stability period of posture stability timer 352 may beof any time duration desired by the manufacturer or clinician, where theclinician may or may not be permitted to set the stability period.Generally, the stability period is between 30 seconds and 30 minutes,but it may be set to any time desired, including times outside of thatrange. More specifically, the stability period may be betweenapproximately 30 seconds and 5 minutes in order to ensure that patient12 engaged in the final desired posture state for a reasonable amount oftime and that the final posture state is not just some transitional orinterim posture state. More preferably, the stability period may bebetween approximately 2 minutes and 3 minutes. In some examples, and asdescribed in the examples of FIGS. 9-13, the stability period isapproximately 3 minutes. Although the search period and stability periodmay have the same duration, they may be different in other examples.

FIG. 10 is a conceptual diagram illustrating example posture searchtimer 354 and posture stability timer 356 with one change in posturestate. As shown in FIG. 10, patient 12 makes an anticipatory therapyadjustment for the next posture state that patient 12 does not currentlyoccupy. In other words, patient 12 makes a therapy adjustment that thepatient may believe is desirable for a given posture, in anticipation ofmovement to that posture on an imminent or near-term basis. Posturesearch timer 354 and posture stability timer 356 start at time T₀ whenpatient 12 makes a therapy adjustment in a current posture stateoccupied at time T₀. At time T₁, patient 12 changes to a second posturestate that is different than the initial posture state occupied at timeT₀. Therefore, posture stability timer 356 restarts at time T₁, with thechange to the new posture state, still within the search duration ofposture search timer 354.

Time T₂ indicates the end of posture search timer 354. Consequently, theonly posture state that processor 80 of IMD 14 will associate with thetherapy adjustment is the second posture state as long as the secondposture state satisfies the stability period of posture stability timer356, i.e., the patient occupies the second posture state for thestability period. At time T₃, patient 12 is still in the second posturewhen the stability period ends, and the therapy adjustment is associatedthen to the second posture state because the stability period overlappedwith the search period.

It should be noted that patient 12 may make additional therapyadjustments within the search period. If this occurs, any previoustherapy adjustments made before the search period or stability period iscompleted are not associated with any posture state. Therefore, both thesearch period and stability period must lapse, i.e., expire, in orderfor a therapy adjustment to be associated with a posture state. However,in some examples, IMD 14 may allow therapy adjustments to be associatedwith posture states as long as the search period has lapsed or nodifferent posture state was sensed during the search period.

FIG. 11 is a conceptual diagram illustrating example posture searchtimer 358 and posture stability timer 360 with two changes in posturestates. As shown in FIG. 11, patient 12 makes an anticipatory therapyadjustment but is engaged in an interim posture state before settlinginto the final posture state. Posture search timer 358 and posturestability timer 360 both start at time T₀ when patient 12 makes atherapy adjustment in a current posture state engaged at time T₀. Thetherapy adjustment value may be an adjustment, a parameter value, or aselection of a program or program group.

At time T₁, patient 12 changes to a second posture state, or an interimposture state, that is different than the initial posture state engagedat time T₀. Therefore, posture stability timer 360 restarts at time T₁,still within the search duration of posture search timer 358. At timeT₂, patient 12 changes to a third posture state, and again posturestability timer 360 restarts. Time T₃ indicates the end of posturesearch timer 358, so the only posture state that processor 80 of IMD 14will associate with the therapy adjustment is the third posture statebegun at time T₂ as long as the third posture state satisfies thestability period of posture stability timer 360. At time T₄, patient 12is still in the third posture when the stability period ends, and thetherapy adjustment is associated then to the third and final posturestate because the stability period of the third posture state overlappedwith the search period.

FIG. 12 is a conceptual diagram illustrating example search timer 362and posture stability timer 360 with the last posture state changeoccurring outside of the posture search timer. As shown in FIG. 12,patient 12 makes an anticipatory therapy adjustment but is engaged in aninterim posture state too long before settling into the final posturestate for the therapy adjustment to be associated with any posturestate. Posture search timer 362 and posture stability timer 364 bothstart at time T₀ when patient 12 makes a therapy adjustment in a currentposture state engaged at time T₀. At time T₁, patient 12 changes to asecond posture state, or an interim posture state, that is differentthan the initial posture state engaged at time T₀. Therefore, posturestability timer 364 restarts at time T₁, still within the searchduration of posture search timer 362.

However, the search timer expires at time T₂, before patient 12 changesto a third posture state at time T₃, when posture stability timer 364again restarts. The stability period for the third posture state thenexpires at time T₄. Since the third posture state did not start beforethe search period expired at time T₂, the search period and stabilityperiod do not overlap and the therapy adjustment from time T₀ is notassociated with any posture state. In other examples, therapyadjustments may still be associated with the posture state occupied attime T₀ when the search period and last stability period do not overlap.

The following is a further illustration of the example described in FIG.12 to put the example in context of an example patient scenario. Patient12 may be engaged in the upright posture state when patient 12 makes thetherapy adjustment at time T₀. In this example, the search duration isthree minutes and the stability duration is also three minutes. Aftertwo minutes, or at time T₁, patient 12 transitions to the lying leftposture, which causes processor 80 of IMD 14 to restart posturestability timer 360.

If patient 12 were to remain within the lying left posture for the fullthree minutes of the stability duration, then the therapy adjustmentwould be associated with the lying left posture. However, patient 12leaves the lying left posture after only two minutes, or at time T₃,outside of the search duration. At this point, the therapy amplitudemade at time T₀ will not be associated with the next posture state ofpatient 12.

The next posture state may be the lying back posture state. Once IMD 14senses the lying back posture state, IMD 14 may change therapy accordingto the therapy parameters associated with the lying back posture,because IMD 14 is operating in the automatic posture response mode. Nonew associations with the therapy adjustment would be made in theexample of FIG. 12.

FIG. 13 is a flow diagram illustrating an example method for associatinga received therapy adjustment with a posture state. Although the exampleof FIG. 13 will be described with respect to patient programmer 30 andIMD 14, the technique may be employed in any external programmer 20 andIMD or other computing device. As shown in FIG. 13, user interface 106receives the therapy adjustment from patient 12 (366) and processor 80of IMD 14 immediately starts the posture search timer (368) and theposture stability timer (370).

If the posture state of patient 12 does not change (372), processor 80checks to determine if the stability period has expired (376). If thestability period has not expired (376), processor 80 continues to sensefor a posture state change (372). If the stability period has expired(376), the processor 80 uses the final posture state, i.e., thecurrently sensed posture state, to select therapy parameters to delivertherapy (382). Processor 80 associates the therapy adjustment with thefinal posture state (384). For example, processor 80 may associate thetherapy adjustment with the final posture state for purposes ofanalyzing therapy efficacy. Processor 80 may also automatically retain,i.e., associate, the therapy adjustment with the final posture state forposture-responsive therapy delivery (386). In this manner, byautomatically associating the therapy adjustment for posture-responsivetherapy delivery, during the next time the patient occupies that finalposture state, the IMD 14 will apply the newly associated therapyadjustment value, thereby automatically defining the therapy to bedelivered for that posture state, at least in part on the basis of theassociated therapy adjustment. If the therapy adjustment value was 5.0volts, then IMD 14 will apply an amplitude value of 5.0 volts the nexttime the patient occupies the posture. Again, the therapy adjustmentvalue may be an adjustment, a parameter value, or a selection of aprogram or program group. In each case, the therapy adjustment valueentered by the patient is used to define a previously undefined therapyparameter value for the respective posture state based on the patientinput.

The search timer and stability timer ensure that the patient is in theposture state or transitioning to the posture state when the patienttherapy adjustment is received. If the search and stability timers aresatisfied, the patient therapy adjustment is associated with the posturestate (384). Hence, in a case in which a plurality of posture states aredefined, and therapy parameter values for at least some of the posturestates are defined, patient input indicating a therapy parameter valuecan be used to define a previously undefined therapy parameter value fora posture state while the patient is in the respective posture state ortransitioning to the respective posture state. The previously undefinedtherapy parameter value then can be defined by the programmer based onthe patient input.

If processor 80 senses a posture state change (372), processor 80determines if the search period has expired (374). If the search periodhas not expired (374), then processor 80 restarts the posture stabilitytimer (370). If the search period has expired (374), then processor 80delivers therapy to patient 12 according to the current posture state(378). Processor 80 retains the therapy adjustment and does notassociate the therapy adjustment with the final posture state becausethe search period did not overlap with the stability period (380).Because the search or stability timer was not satisifed, the therapyadjustment cannot be reliably associated with the posture state.Consequently, the pertinent therapy parameter value remains undefined.

In some embodiments, a posture stability timer may be employed withoutthe use of a posture search timer. As described with respect to posturestability timer 350, the posture stability timer may be started after atherapy adjustment and reset each time patient 12 changes posture statesprior to expiration of the posture stability timer. When the posturestability timer expires, the therapy adjustment may be associated withthe posture state that patient 12 is occupying at that time. In thismanner, the therapy adjustment may be associated with the first stableposture state, i.e., the first posture state that remains stable for theduration of the posture stability timer, after the therapy adjustmentregardless of the amount of time that has past since the therapyadjustment.

Any patient therapy adjustments may be applied immediately followingreceipt of the adjustments. However, processor 80 may not change posturestate-responsive therapy to patient 12 at any time until the stabilityperiod expires. In other words, the posture stability timer may runindependently of the posture search timer to always track posture statesindependently of therapy adjustments. Therefore, IMD 14 may not performany automatic posture responsive stimulation until the posture state ofpatient 12 is stable and the stability period has expired. In thismanner, patient 12 may not be subjected to rapidly changing therapy whentransitioning between multiple posture states. Alternatively, IMD 14 mayemploy a separate posture stability timer for changing therapy duringautomatic posture response from the therapy adjustment related posturestability timer described herein.

FIG. 14 is a conceptual diagram illustrating an example user interface168 of a patient programmer 30 for delivering therapy information topatient 12. In other examples, a user interface similar to userinterface 168 may also be shown on clinician programmer 60. In theexample of FIG. 14, display 36 of patient programmer 30 provides userinterface 168 to the user, such as patient 12, via screen 170. Screen170 includes stimulation icon 174, IMD battery icon 176, programmerbattery icon 178, navigation arrows 180, automatic posture response icon182, group selection icon 184, group identifier 186, program identifier188, amplitude graph 190, and selection box 192. User interface 168provides information to patient 12 regarding group, program, amplitude,and automatic posture response status. User interface 168 may beconfigurable, such that more or less information may be provided topatient 12, as desired by the clinician or patient 12.

Selection box 192 allows patient 12 to navigate to other screens,groups, or programs using navigation arrows 180 to manage the therapy.In the example of screen 170, selection box 192 is positioned so thatpatient 12 may use navigation buttons 44 and 48 to move to the automaticposture response screen, the volume screen, the contrast or illuminationscreen, the time screen, and the measurement unit screen of patientprogrammer 30. In these screens, patient 12 may be able to control theuse of the automatic posture response feature and adjust the patientprogrammer 30 features. Patient 12 may only adjust the featuressurrounded by selection box 192.

Group identifier 186 indicates one of possibly several groups ofprograms that can be selected for delivery to patient 12. Groupselection icon 184 indicates whether the displayed group, e.g., group Bin FIG. 14, is actually selected for delivery to patient 12. If apresently displayed group is selected, group selection icon 184 includesa box with a checkmark. If a presently displayed group is not selected,group selection icon 184 includes a box without a checkmark. To navigatethrough the program groups, a user may use control pad 40 to moveselection box 192 to select the group identifier 186 and then usecontrol pad 40 to scroll through the various groups, e.g., A, B, C, andso forth. IMD 14 may be programmed to support a small number of groupsor a large number of groups, where each group contains a small number ofprograms or a large number of programs that are deliveredsimultaneously, in sequence, or on a time-interleaved basis.

For each group, group selection icon 184 indicates the appropriatestatus. For a given group, program identifier 188 indicates one of theprograms associated with the group. In the example of FIG. 14, noprogram number is indicated in program identifier 188 because all of theprograms' amplitudes are shown in each bar of amplitude graph 190. Solidportions of the bars indicate the relative amplitude IMD 14 currently isusing to deliver stimulation therapy to patient 12, while open portionsof the bars indicate the remaining amplitude available for each program.In some embodiments, numerical values of each program's amplitude may beshown in addition to or in place of amplitude graph 190. In otherembodiments of user interface 168 specific to drug delivery using IMD26, amplitude graph 190 may show the flow rate of drugs or frequency ofbolus delivery to patient 12. This information may be shown in numericalformat as well.

Automatic posture response icon 182 indicates that IMD 14 is generallyactivated to automatically change therapy to patient 12 based upon theposture state detected by posture state module 86. However, automaticposture response icon 182 is not present next to group identifier 186.Therefore, group “B” does not have automatic posture response activatedfor any of the programs within group “B.” Some groups or individualprograms in groups may have automatic posture response, i.e., automaticadjustment of one or more therapy parameters in response to posturestate indication, selectively activated or deactivated based on settingsentered by a clinician, or possibly patient 12. In some cases, ifposture responsive therapy supported by the automatic posture responsefeature is desired, patient 12 may need to switch therapy to a differentgroup that has automatic posture response activated for IMD 14 to adjusttherapy according to the patient 12 posture state.

FIG. 15 is a conceptual diagram illustrating an example user interface168 of a patient programmer 30 for delivering therapy information thatincludes posture information to the patient. In other examples, userinterface 168 may also be shown on clinician programmer 60. In theexample of FIG. 15, display 36 of patient programmer 30 provides userinterface 168 to the user, such as patient 12, via screen 194. Screen194 includes stimulation icon 174, IMD battery icon 176, programmerbattery icon 178, and automatic posture response icon 182, similar toscreen 170 of FIG. 14. In addition, screen 194 includes group selectionicon 184, group identifier 186, supplementary posture state indication202, program identifier 196, posture state indication 200, amplitudevalue 204, selection box 192, and selection arrows 180. User interface168 provides information to patient 12 regarding group, program,amplitude, automatic posture response status, and posture stateinformation. More or less information may be provided to patient 12, asdesired by the clinician or the patient. For example, in someembodiments, user interface 168 may provide information regardingadditional therapy parameters, such as rate, pulse width, and electrodeconfiguration (e.g., electrode combination and polarities).

Group identifier 186 indicates that group “B” is active, and automaticposture response icon 182 indicates group “B” (containing one or moreprograms) is activated to allow IMD 14 to automatically adjust therapyaccording to the patient 12 posture state. Specifically, the patient 12posture state is the patient's certain posture in the example of FIG.15. Program identifier 196 illustrates that information regardingprogram “1” of group “B” is displayed on screen 194, such as amplitudevalue 204 illustrating the current voltage amplitude of program “1” is2.85 Volts. Patient 12 may scroll through different programs of thegroup by using navigation arrows 180 via navigation buttons 44 and 48 ofcontrol pad 40.

In addition, posture state icon 200 shows that IMD 14 is detecting thatpatient 12 is in the upright or standing posture. Posture state text 202supplements posture state icon 200 by explaining in words to patient 12what posture is being detected by posture state module 86 of IMD 14.Posture state icon 200 and posture state text 202 changes according tothe detected posture state detected by IMD 14. Selection box 192indicates that patient 12 may view other programs within group “B” usingselection arrows 180. Selection box 192 may be moved to select otherscreen levels with control pad 40 in order to navigate through otherstimulation groups or adjustable elements of the therapy. When patient12 selects a different program with control pad 40, program identifier196 will change number to correctly identify the current program viewedon screen 194

The posture state may be communicated to the external programmerimmediately when IMD 14 detects a posture change, or communicatedperiodically or non-periodically by IMD 14 unilaterally or uponreceiving a request from the programmer. Accordingly, the posture stateindication 200 and/or supplementary posture state indication 202 mayrepresent a current, up-to-the minute status, or a status as of the mostrecent communication of posture state from IMD 14. Posture stateindication 200 is shown as a graphical representation, but the posturestate indication may alternatively be presented as any one of a symbolicicon, a word, a letter, a number, an arrow, or any other representationof the posture state. In some cases, posture state indication 200 may bepresented without supplementary posture state indication 202.

As mentioned above, in addition to graphical, textual or other visibleindications of posture state, the external programmer may presentaudible and/or tactile indications of posture state via any of a varietyof audible or tactile output media. Again, an audible indication may bespoken words stating a posture state, or different audible tones,different numbers of tones, or other audible information generated bythe programmer to indicate posture state. A tactile indication may bedifferent numbers of vibratory pulses delivered in sequence or vibratorypulses of different lengths, amplitudes, or frequencies.

FIG. 16 is a conceptual diagram illustrating an example screen 250 thatmay be displayed by user interface 210 of a clinician programmer 60 topresent posture information to a user, such as a clinician. Examplescreen 250 also or alternatively could be provided on a user interfaceof patient programmer 30, in some embodiments. In the example of FIG.16, display 64 of clinician programmer 60 provides screen 250 to theuser via user interface 210. Screen 250 includes stimulation icon 214,programmer battery icon 216, operational menu 224, selection box 226,group selection list 238, posture state selection list 240, clear button242, and program button 244. Selection of operational menu 224 may allowa user to adjust the volume, contrast, illumination, default printer,clock, or other similar options of clinician programmer 60. As describedin further detail below, screen 250 permits a user to link posturestates together for posture-responsive therapy. Other examples of screen250 may provide more or less information to the user.

Selection box 226 includes patient data icon 228, data recording icon230, device status icon 232, programming icon 234, and data reportingicon 236. Selection box 226 may allow the user to navigate to otherscreens to manage therapy delivery. For example, each of icons 228-236may be selected to display other therapy information. Additionally, eachof icons 228-236 may serve as a drop-down menu that allows selection ofvarious subcategories. As one example, programming icon 234 may displaya list of programming subcategories available for user selection, suchas create new program, program stimulation, orient device, restoreinitial settings, and the like.

Screen 250 may allow a user to link various posture states for purposesof posture-responsive therapy. When a set of linked posture states areselected for posture-responsive therapy, one set of therapy parametervalues may be associated with all of the linked posture states. Forexample, when a set of therapy parameter values is associated with oneposture state of a set of linked posture states, the set of therapyparameter values may be automatically associated with the additionalposture states of the set of linked posture states. In this manner, aset of therapy parameter values may be conveniently and efficientlypropagated across several posture states so that there is no need toenter multiple sets of identical therapy parameter values. Also, in someembodiments, linking a plurality of posture states may enable or disabletherapy delivery features. For example, linking a plurality of posturestates may disable cycling (e.g., cycling between an “on” period oftherapy delivery and an “off” period without therapy delivery), pulserate adjustment, and/or pulse width adjustments.

Often, different posture states may be associated with different therapyparameter values. When the same therapy parameter values can be used formultiple posture states, either as an initial starting point orchronically, this linking feature provides an expeditious mode forprogramming. Additionally, when a user adjusts a set of therapyparameter values for one posture state of the set of linked posturestates, the adjustment may be automatically made for the additionalposture states of the set of linked posture states. In other words,changes to a therapy parameter value set may be automatically propagatedamong any other posture states identified as being linked to oneanother, permitting global or semi-global changes to be quickly made.

Hence, using screen 250, a user can link linking a plurality of posturestates of a patient, and select a program group to apply to the linkedposture states. In this manner, by selecting a program group, the userselects a set of therapy parameter values for delivery of therapy to thepatient 12 by IMD 14 for each of the linked posture states. Based onthis user selection, programmer 60 defines the therapy to be deliveredto the patient by IMD 14 for each of the linked posture states. Thedefined therapy can be downloaded to IMD 14 as program instructions. IfIMD 14 is configured to recognize the linking concept, programmer 60 maysimply download the linking information and the group or groups to beapplied to the link. If IMD 14 does not recognize the linking concept,programmer 60 may download an explicit indication of the program groupto be used for each of the linked posture states.

The user may select which posture states to link using posture stateselection list 240. In the example of FIG. 16, in addition to theindividual posture states, posture state selection list 240 includeslistings for “All Posture States” and “All Lying States.” These listingsmay allow a user to select all of the posture states or all of the lyingposture states, e.g., “Lying (Back),” “Lying (Front),” “Lying (Right),”and “Lying (Left),” simultaneously. If the user would like to linkseveral posture states, selecting all of the postures statessimultaneously and then deselecting individual posture states may bemore efficient than selecting all of the desired posture statesindividually. Allowing a user such as a clinician or patient to selectthe same therapy parameter values for all of the lying posture statessimultaneously may be beneficial, especially when the same therapyparameter values may be used for all of the lying posture states.

Additionally, the user may select which groups to apply to the set oflinked posture states group selection list 238, which displays a listingof groups that are available for selection for therapy delivery topatient 12. In the example of FIG. 16, group selection list 238 includesa listing for “All Groups,” which may allow a user to select all of thegroups simultaneously. Then, the user may deselect some of the groups toleave only desired groups selected. Selecting all groups provides ashortcut in the event numerous groups are to be selected. Each group maydefine a group of programs, and each program may define a set of therapyparameter values. The programs in a given group may be used to controltherapy parameter values for delivery of different or related therapieson a simultaneous or time-interleaved basis.

For example, group “A” may specify that programs 1, 2 and 4 are to bedelivered together (simultaneously or time-interleaved). The individualprograms specify the therapy parameter values for each program, e.g.,amplitude, pulse width, pulse rate, electrode configuration, or thelike. Accordingly, specification or adjustment of therapy parametervalues for different posture states or linked posture states may referto specification or adjustment of individual therapy parameter values,specification or selection of different programs in a group, orspecification or selection of different groups.

Linked posture states may be selected on a group-by-group basis.Alternatively, in some embodiments, posture states may automatically belinked for all groups rather than allowing the user to select whichparticular program groups will use a set of linked posture states. Theuser may also create more than one set of linked posture states usinglink button 252. In response to activation of link button 252, screen250 may display an additional posture state selection list 240 and groupselection list 238 to allow the user to define a second set of linkedposture states. In this case, the user may specify multiple sets ofdifferent linked posture states and associate the individual sets oflinked posture states with particular groups, on a selective basis.

In the example of FIG. 16, a user has selected to link the fourdifferent lying posture states, e.g., “Lying (Back),” “Lying (Front),”“Lying (Right),” and “Lying (Left),” together. This means that all ofthe linked posture states will share the same set of therapy parametervalues, e.g., in terms of values associated with a program or group ofprograms. The user may have selected to link the four lying states byselecting the “All Lying States” listing. The selection of a posturestate is indicated by displaying a check mark in the box next to thename of the posture state within posture state selection list 240. Uponselection of “All Lying States,” check marks may automatically bedisplayed next to the name of the lying posture states. Boxes withoutcheck marks are displayed next to unselected posture states.

When the set of linked posture states is selected for posture-responsivetherapy, a single set of therapy parameter values may be associated witheach of the four linked lying posture states. When the patient entersany of the four lying posture states, e.g., any of the posture statesassociated with the four lying states, he will receive the same therapy.Additionally, if the set of therapy parameter values is adjusted for onelying posture state, the adjustment will be automatically made for allof the lying posture states in the set of linked posture states. Forexample, when a patient or clinician adjusts a therapy parameter valuefor one posture state, programmer 60 may apply the same therapyparameter adjustment for all linked posture states.

Additionally, in the example of FIG. 16, the user has selected to linkthe lying group posture states for program group “A.” Similar to posturestate selection list 240, a check mark next to a group name mayrepresent that the program group is selected. Boxes without check marksare displayed next to unselected groups. As previously stated, in otherembodiments, posture states may automatically be linked for all groupsrather than allowing the user to select which program groups will usethe set of linked posture states.

By selecting posture states to be linked, the user may specify posturestates that will share the same therapy parameter values, e.g., in termsof specific values, programs, or groups. The example of FIG. 16contemplates sharing of the same groups among linked posture states suchthat changes to therapy parameter values for programs in a given group,when the patient is in one posture state of the set of linked posturestates, are applicable to all other posture states in the set of linkedposture states. In this manner, assuming the “Lying (Back)” and “Lying(Right)” posture states are linked, if the patient changes an amplitudeassociated with a program in a given group while occupying the “Lying(Right)” posture state, then the same change will be effective for the“Lying (Back)” posture state, because the two posture states are linked.The changes may be entered by a patient during the course of therapy,for example, or entered by a clinician in the clinic or remotely.

By selecting groups to which linking will be applied, the user mayspecify the groups for which linking is active. If the user selectschecked Group A, in the example of FIG. 16, any changes to the therapyparameter values associated with Group A will be active across the setof linked posture states with regard to the particular posture state(among the linked posture states) that was occupied by the patient whenthe change was made. This is because Group A is considered to belinking-active. However, if the user selects unchecked Group B and makesa change to a therapy parameter value in Group B while residing in agiven posture state, that change will not be effective for the otherposture states in the set of linked postures states, because linking isnot activated for Group B, i.e., Group B is linking-inactive. In thiscase, Group B may be selected for different posture states within theset of linked posture states, but changes will only apply for the givenposture state occupied by the patient when the change is made. Hence,selection of groups to link specify those groups for which linking willbe given effect among the linked posture states. Again, if a particulargroup is selected for one posture state, and the selected group is notlink-active, then any therapy parameter changes made to that group forthe one posture state will not be applied for the other posture states.

FIG. 16 illustrates linking of posture states on a selective basis andselection of program groups for which linking will be active, i.e.,program groups for which linked posture states will share the sametherapy parameter values and changes. Patient programmer 30 and/orclinician programmer 60 may allow linking of posture states andselection of program groups for which linking will be active. Ingeneral, selection of linked posture states and link-active programgroups may be significant for purposes of initially programmingtherapies for different posture states, adjusting such therapiesdynamically during trial or chronic usage by the patient, and thentransitioning among different therapies during operation ofposture-responsive therapy control.

In particular, the IMD is configured to select groups, programs withingroups, or therapy parameter values for the programs when a patienttransitions from one posture state to another posture state. Theselection is based on the particular groups, programs and therapyparameter values specified for each posture state. The particulargroups, programs and therapy parameter values specified for each posturestate can be selected individually or, as described with reference toFIG. 16, by linking posture states. Hence, the linking and link-activegroup selection determines the changes (or lack of changes) made by theIMD for each posture state when a posture state change is detected.

Once a user such as a clinician or patient has specified linking andlink-active groups for an IMD, the IMD may thereafter function accordingto those specifications. For example, when the IMD detects a transitionfrom a first linked posture state to a second linked posture state, anddetermines that the current Group is linking-active, the IMD does notchange therapy because the posture states are linked and should receivethe same therapy, assuming selection of a linking-active group. If theIMD detects a transition between previous and current posture statesthat are not linked with one another, however, the IMD may adjusttherapy according to the therapy parameter values specified for thecurrent posture state.

Linking posture states may enhance the efficiency and ease ofprogramming the IMD by a clinician either in-clinic or remotely. Theclinician may quickly propagate changes among linked posture states witha single change rather than multiple, individual changes. In thismanner, the disclosure contemplates, in some embodiments, a system thatmay permit the granularity to assign individual therapy parametervalues, programs and/or groups to individual posture states, but alsopermit more global or semi-global adjustments when a clinician does notnecessarily require fine grain adjustment, but instead may be satisfiedwith the same therapy for different groups of linked postures states(e.g., all of the lying posture states).

In addition to facilitating programming for multiple posture states, thedisclosure contemplates the ability, in some embodiments, to propagatepatient therapy parameter value changes among multiple linked posturestates. For example, the IMD may be configured to change parametervalues based on parameter value adjustments entered manually by apatient during the course of therapy, e.g., amplitude adjustments. Inthis case, when the patient makes a manual adjustment while occupying acurrent posture state, that adjustment may be used for all of theposture states linked to the current posture state, provided that thecurrent therapy program group that is being applied has been specifiedas link-active. As further options, linking and link-active status maybe specified by the clinician and statically fixed for use by the IMD,or the patient may be given the opportunity to modify linking andlink-active status, e.g., via a patient programmer.

With further reference to FIG. 16, screen 250 also may displayprogramming flags 246 to indicate that recent selections have not beensaved. The user may use clear button 242 to clear the selections flaggedwith programming flags 246 or program button 244 to save the selectionsflagged with programming flags 246. In order for program button 244 tobe enabled, screen 250 may require that at least two posture states fromposture state selection list 240 and at least one group from groupselection list 238 be selected.

FIGS. 17A-17C are conceptual diagrams illustrating an example userinterface 210 of clinician programmer 60 for displaying therapyinformation that includes posture information to a user, such as aclinician. In the example of FIGS. 17A-17C, display 64 of clinicianprogrammer 60 provides screens 212A-212C, respectively, (collectively“screens 212”) to the user via user interface 210. Screens 212 permit auser to select which program groups to apply posture-responsive therapy.Other examples of screens 212 may provide more or less information tothe user.

As illustrated in FIG. 17A, a user such as a clinician or patient mayselect one or more groups for posture-responsive therapy via groupselection list 238. Group selection list 238 may include an “All Groups”listing that permits a user to simultaneously select all of the programgroups. The “All Groups” listing may be selected if a user would like toselect all of the program groups for posture-responsive therapy andapply posture-responsive therapy to the same posture states for each ofthe program groups.

In the example of FIG. 17A, a user has selected group “A” forposture-responsive therapy. As previously described, the selection of agroup may be indicated by displaying a check mark in the box next to thegroup name. Boxes without check marks are displayed next to unselectedgroups. If a group is selected for posture-responsive therapy, the IMDautomates selection of different therapy parameter values for the groupwhen the patient transitions between different posture states. If agroup is not selected for posture-responsive therapy, then the IMD doesnot automatically select different therapy parameter values based onchanges in the detected posture state.

Upon selection of a group for posture-responsive therapy via groupselection list 238, a user may select which posture states to applyposture-responsive therapy to for the selected group (e.g., “A” in theexample of FIG. 17A) via posture state selection list 240. When a userselects a group for posture-responsive therapy, all posture states forwhich the group is applied may be selected for posture-responsivetherapy by default. If the entire list of posture states is selected bydefault, the user may unselect any posture states for which he would notlike to implement posture-responsive therapy via posture state selectionlist 240. Alternatively, the user may be required to actively selecteach of the desired posture states to which posture-responsive therapywill be applied using posture state selection list 240. In the exampleof FIG. 17A, posture state selection list includes an “All Postures”listing that may allow a user to select all of the posture statessimultaneously.

If one or more posture states are linked together for the selectedgroup, unselecting or selecting one posture state of the set of linkedposture states may automatically unselect or select the additionalposture states of the set. For example, if “Lying (Back)” and “Lying(Front)” are linked and the selected group (e.g., “A” in FIG. 17A) islink-active, then selecting or deselecting the “Lying (Front)” posturestate results in selection or deselection of the “Lying (Back)” posturestate. In this manner, all the posture states of a set of linked posturestates may either be selected or unselected for posture-responsivetherapy together rather than individually.

In the example of FIG. 17A, screen 212A includes “Link all lyingpostures” button 248. “Link all lying postures” button 248 may allow auser to link the lying posture states (e.g., “Lying (Back)”, “Lying(Front)”, “Lying (Right)”, and “Lying (Left)”) for the selected group(e.g., “A” in FIG. 17A) without navigating to a separate screen (e.g.,screen 250 of FIG. 16). In this manner, the lying posture states may beconveniently and efficiently linked together so that there is no need toenter separate therapy parameter values and/or adjustments for eachlying posture state. This may be particularly beneficial when one set oftherapy parameter values may provide efficacious therapy to patient 12when patient 12 is positioned in any of the four lying posture states.

Screen 212A may display programming flags 246 to indicate that recentselections have not been saved. The user may use clear button 242 toclear the selections flagged with programming flags 246 or programbutton 244 to save the selections flagged with programming flags 246. Inorder for program button 244 to be enabled, screen 212A may require thatat least one posture state from posture state selection list 240 beselected for the selected program group. FIG. 17B illustrates screen212B, which is displayed after the user has saved the selectionsillustrated in FIG. 17A using program button 244. As illustrated in FIG.17B, screen 212B no longer displays programming flags 246.

In the example of FIG. 17C, a user has selected to applyposture-responsive therapy for group “B” via group selection list 238 ofscreen 212C. Additionally, the user has specified a subset of theposture states displayed via posture state selection list 240 forposture-responsive therapy. As described previously, if all posturestates within a group are selected for posture-responsive therapy bydefault, when a user selects a group for posture-responsive therapy, theuser may unselect any posture states for which he would not like toimplement posture-responsive therapy for the selected group via posturestate selection list 240. Alternatively, the user may be required toselect the desired posture states for posture-responsive therapy usingposture state selection list 240. As another alternative, as illustratedin FIGS. 17A-17C, posture state selection list 240 may include an “AllPostures” listing. A user may use the “All Postures” listing to selectall of the posture states and, if applicable, unselect any undesiredposture states. If one or more posture states are linked together forthe selected group, unselecting or selecting one posture state of theset of linked posture states may automatically unselect or select theadditional posture states of the set of linked posture states.

As shown in FIGS. 17A-17C, a user such as a clinician or patient mayselectively define the program groups for which posture responsivetherapy is to be performed by the IMD (“Select a group to automate”)and, for each group, selectively define the posture states to whichposture responsive therapy will be applied (“Select postures toautomate”). Again, a program group may refer to a set of one or moreprograms that are delivered simultaneously or on a time-interleaved orordered basis by the IMD, and each program defines a set of therapyparameter values, where the therapy parameter values for each programmay include voltage or current amplitude, pulse width, pulse rate, andelectrode configuration (e.g., electrode combination and polarities).

Also, posture responsive therapy generally refers to a mode in which theIMD automatically or semi-automatically adjusts therapy parameter valuesaccording to the posture states occupied by a patient, such thatdifferent therapy parameter values may be applied for different posturestates, and where the adjustment of therapy parameter values may bespecified by selection or modification of individual therapy parametervalues, programs and/or groups. FIGS. 17A-17C and the description abovegenerally describe techniques for effective management of differentgroups and posture states to which patient responsive therapy may beapplied, in order to facilitate programming by a clinician or patient.

FIGS. 18A-18D are conceptual diagrams illustrating example screens thatmay be displayed by user interface 210 of clinician programmer 60 topresent posture information to a user, such as a clinician. In theexample of FIGS. 18A-18D, display 64 of clinician programmer 60 providesscreens 260A-260D, respectively, (collectively “screens 260”) to theuser via user interface 210. Screens 260 include group tab 262, programtabs 264, group selection menu 266, posture state selection menu 268,delete group button 270, save current settings to button 272, andactivate therapy button 274. Additionally, for each program of theselected group, screens 260 include a program on/off icon 276, programon/off check box 278, program name text 280, pulse width text 282, pulserate text 284, electrode configuration icon 286, decrease amplitudebutton 288, amplitude text 289, and increase amplitude button 290. Otherexamples of screens 260 may provide more or less information to theuser.

In some embodiments, an auto-repeat feature may be implemented fordecrease amplitude button 288 and increase amplitude button 290 suchthat the amplitude is decreased or increased accordingly as long asdecrease button 288 or increase button 290 is held down. Additionally oralternatively, a scroll wheel may be provided to adjust amplitude. Forexample, upon clicking on amplitude text 289, a scroll wheel may then beused to perform amplitude adjustment.

In the example of FIG. 18A, group “C” is activated and the currenttherapy settings delivered by the IMD (or to be delivered by the IMD)are displayed. Group selection menu 266 indicates that group “C” isdisplayed. Additionally, the quotation marks around group “C” on groupselection menu 266 indicate that group “C” is activated, i.e., isactively being delivered by the IMD. If group “C” were not activated,the quotation marks would not be displayed. Also, program on/off icons276 indicate that the displayed programs (1, 2, 3) forming part of group“C” and their respective therapy parameters, e.g., displayed via pulsewidth text 282, pulse rate text 284, electrode configuration icon 286,and amplitude text 289, are activated. The individual programs 1, 2, 3of group “C”, in this example, address pain symptoms associated with thelower back, foot and lower leg.

When the displayed therapy parameters are active, program on/off icons276 are bolded. In contrast, when the displayed therapy parameters arenot activated, program on/off icons 276 are not bolded. Additionally,program on/off check boxes 278 may only be displayed when the displayedprogram group is activated. Program on/off check boxes 278 may be usedto turn an individual program within a group on and off when the programgroup is activated. As an additional indicator, activate therapy button274 is disabled when the displayed group is already activated fortherapy delivery.

When the therapy parameters displayed for a program are activated, auser such as a clinician or patient may decrease or increase theamplitude of stimulation for that program, e.g., using buttons 288 and290, respectively. Additionally, the user may navigate to individualprogram screens for each program via program tabs 264 to adjust othertherapy parameter values. A user may also turn individual programswithin the selected group on and off using program on/off check boxes278. Disabling one or more programs using program on/off check boxes 278may allow a user to program posture-responsive therapy at the programlevel rather than the group level. As will be described in furtherdetail below, the current stimulation settings may be saved to any ofthe posture states selected for posture-responsive stimulation via savecurrent settings to button 272.

A user may navigate from screen 260A of FIG. 18A to screen 260B of FIG.18B by selecting the upright posture state from posture state selectionmenu 268. Posture state selection menu 268 may only allow selection ofposture states that have been selected for posture-responsive therapy.Screen 260B illustrates the therapy settings associated with the uprightposture state, including the amplitude values. In the example of FIG.18B, the upright settings are not active. Therefore, the user may not bepermitted to decrease or increase the stimulation amplitude, e.g., viabuttons 288 and 290. The user may only be allowed to change the therapysettings of programs that are activated, i.e., are actively beingdelivered by the IMD.

As described previously, program on/off icons 276 indicate whether theprograms and their displayed therapy parameters, e.g., displayed viapulse width text 282, pulse width text 284, electrode configuration icon286, and amplitude text 289, are activated. In the example of FIG. 18B,program on/off icons 276 are not bolded. Therefore, the displayedtherapy parameters are not activated. As another indicator, activatetherapy button 274 is enabled, suggesting that the displayed programgroup is not in use to deliver therapy. A user may transition fromscreen 260B of FIG. 18B to screen 260C of FIG. 18C by activating theprogram group associated with the upright posture state using activatetherapy button 274.

Additionally, a user may navigate from screen 260C of FIG. 18C to screen260D of FIG. 18D by selecting the lying back posture state from posturestate selection menu 268. As previously stated, posture state selectionmenu 268 may only permit selection of posture states that have beenselected for posture-responsive therapy. In the example of FIG. 18D,screen 260D displays question marks (?) for the amplitude values inamplitude text 289, because the amplitudes have not been defined forthis particular posture state. In some cases, the clinician or otheruser of clinician programmer 60 may leave one or more therapy parametervalues for the patient to define. In this manner, the posture state maybe selected for posture-responsive therapy but not have a complete setof therapy parameter values associated with it. In some cases, theclinician or other user of clinician programmer 60 may leave all of thetherapy parameter values for the patient to define. In other cases, theclinician or other user of clinician programmer 60 may define a completeset of therapy parameter values such that all of the therapy parametervalues are at least initially clinician-defined.

In the example of FIG. 18D, the amplitude value is undefined for thelying back posture state. When patient 12 first enters the lying backposture state, he may continue to receive the set of therapy parametervalues that he was previously receiving, such as the set of therapyparameter values associated with the posture state in which hepreviously resided. For example, if patient 12 enters the lying backposture state from the upright posture state, and the upright posturestate has an associated set of therapy parameter values, patient 12 mayreceive the therapy parameter values associated with the uprightposture. When patient 12 makes an adjustment to the amplitude value forthe lying back posture state, e.g., when patient 12 is in the lying backposture state or is transitioning to the lying back posture state, theadjusted amplitude value may be associated with the lying back posturestate. As described previously with respect to FIGS. 9-13, theassociation may be subject to search and stability periods to ensurethat the adjustment is associated with the intended posture state. Forexample, when patient 12 adjusts a value of a therapy parameter that isundefined for the posture state in which he is positioned or to which heis transitioning, the adjusted value of the therapy parameter value maybe automatically associated with the appropriate posture state using thetechniques described with respect to FIGS. 9-13, e.g., for purposes ofposture responsive therapy. Upon subsequent detection of the lying backposture state, patient 12 will receive therapy according to theamplitude and other therapy parameter values associated with the lyingback posture state. By allowing patient 12 to define one or more therapyparameter values, the amount of programming time required by theclinician may be decreased.

When one or more therapy parameters for a posture state are undefinedand patient 12 first enters the posture state, patient 12 may continueto receive therapy according to the set of therapy parameter values thathe was receiving prior to entering the posture state. As anotherexample, if some therapy parameter values are defined and others areundefined for the posture state, patient 12 may receive therapy using acombination of the defined therapy parameter values associated with theposture state and therapy parameter values that he was receiving priorto entering the posture state for the therapy parameters that areundefined. In the example of FIG. 18D where only the amplitude value isundefined, patient 12 may receive therapy using the therapy parametervalues associated with the lying back posture state and an amplitudevalue that was used to deliver therapy before patient 12 entered theposture state. An amplitude or other therapy parameter value may beundefined when a clinician or patient has not previously specified avalue for the parameter. In some cases, one or more therapy parametervalues may be left undefined, at least initially when patient 12 beginsto receive posture state-responsive therapy.

When patient 12 adjusts a value of a therapy parameter that is undefinedfor the posture state that he is positioned in or transitioning to, theadjusted value of the therapy parameter value may be automaticallyassociated with the posture state, e.g., for purposes of postureresponsive therapy. For example, if patient 12 specifies a voltageamplitude of 5.0 volts for a voltage parameter that was previouslyundefined for the posture state, the voltage amplitude specified bypatient 12 will then be used as the voltage amplitude for the posturestate. In this case, when the patient 12 occupies the posture stateagain in the future, the IMD may select therapy parameter valuesincluding the adjusted therapy parameter value that was specified by theuser when the value was undefined. In effect, the therapy parametervalue is no longer undefined. Rather, the value of the therapy parameteradjustment specified by the patient 12 is used to define the previouslyundefined therapy parameter value. Alternatively, in response toreceiving the adjustment from patient 12, patient programmer 30 mayrequest that patient 12 indicate whether to associate the adjusted valuewith the posture state, i.e., obtain patient approval or confirmationprior to giving effect to the adjustment by associating it with theposture state to define the previously undefined therapy parameter valuefor the posture state.

As yet another alternative, once patient 12 adjusts one or more of thetherapy parameter values as desired for the posture state, patient 12may be permitted to associate the therapy parameter values for theposture state with one or more other posture states using patientprogrammer 30. In some embodiments, patient 12 may be permitted toassociate a current therapy parameter value or set of a therapyparameter values with a posture state regardless of whether the patientis actually positioned in that posture state. In particular, patient 12may be permitted to associate a current therapy parameter value for acurrently occupied posture state with another posture state that isdifferent from the currently occupied posture state.

In this manner, patient 12 may define one or more therapy parametervalues for another posture state without actually occupying that otherposture state. The therapy parameter values may replace previouslydefined therapy parameter values for the other posture state orpreviously undefined therapy parameter values for the other posturestate. The patient 12 may, in some implementations, associate one ormore selected therapy parameter values, currently being applied to thecurrent posture state, to the other posture state or multiple posturestates, or associate all of the selected therapy parameter values forthe current posture state. For example, a user may wish to associateonly a voltage amplitude value from the current posture state to adifferent posture state or states.

FIG. 19 is a conceptual diagram illustrating an example screen 300 thatmay be displayed by user interface 210 of clinician programmer 60 topresent posture information to a user, such as a clinician. In theexample of FIG. 19, display 64 of clinician programmer 60 providesscreen 300 to the user via user interface 210. Other examples of screen300 may provide more or less information to the user.

Screen 300 of FIG. 19 may be displayed when the user selects to save thecurrent therapy settings to a different posture state via save currentsettings to button 272 of FIGS. 18A-18D. The current therapy settingsmay include the therapy parameter values presently selected or presentlybeing applied to the patient for the current posture state. For example,when a program group is activated to deliver therapy for a currentposture state, the user may select to save the current therapy settingsfrom the group to one or more other posture states in which the patient12 is not presently residing. The patient 12 may associate or save thecurrent therapy settings to one or more other posture states via savecurrent settings to button 272 (FIG. 18A). In response to actuation ofsave current settings to button 272, screen 300 may display posturestate selection list 240. A user may select which posture states to savethe current therapy settings to using posture state selection list 240.Posture state selection list 240 may include an “All Postures” listing,which may permit a user to select all of the postures states automatedfor posture-responsive therapy to be selected simultaneously.

Saving the current therapy settings to multiple posture states selectedfor posture-responsive stimulation may provide an initial starting pointfor therapy delivery for each of the posture states and decrease initialprogramming time. Once therapy settings are specified for a currentposture state, the patient 12 may feel comfortable using the sametherapy settings as a starting point for further refinement for otherposture states, and possibly all posture states. Some therapy parametervalues may be known by the clinician to be safe for any posture state,and therefore can be associated with one or more posture statesregardless of whether these parameters are currently being, or ever werepreviously, used to deliver therapy. Therapy settings may be furtherrefined during chronic use for each of the posture states to obtainacceptable or optimal therapy parameter values for each posture state.

For example, as a patient makes therapy adjustments during chronic use,different therapy settings may be associated with posture states thatwere initially associated with common therapy settings. Initially,however, associating therapy settings with multiple posture states mayprovide significant efficiency, possibly decreasing upfront programmingtime by the clinician while allowing further refinement by the patient12 as needed. Instead of remaining in the clinic for an extended periodof time in order to receive settings for all posture states, the patient12 may leave with a baseline set of therapy parameter settings that wereestablished for one posture state and then associated with the otherposture states. The patient 12 then can experiment with adjustments tothe baseline set of therapy parameters. Although therapy parameters canbe saved from one posture state to another to define therapy parametersthat were previously undefined, the same can be performed to redefinetherapy parameters that were previously defined. In some cases, if thereare already existing, i.e., previously defined, therapy parameters for aparticular posture state, programmer 60 may present a message asking thepatient 12 whether they would like to proceed to overwrite the existingtherapy parameters for the posture state.

As one example, screen 300 of FIG. 19 may be displayed on clinicianprogrammer 60 to allow the clinician to apply a current therapyparameter value or a set of therapy parameter values to multiple posturestates, e.g., as an initial baseline state of therapy parameter values.The current therapy parameter value or set of current therapy parametersmay be currently displayed and/or currently delivered to patient 12. Forexample, the clinician may associate one or more therapy parametervalues known to be safe for any posture state with one or more posturestates regardless of whether these parameters are currently being, orever were previously, used to deliver therapy. The associated therapyparameter values then may define the therapy delivered via the multipleposture states. The clinician may associate the parameter values withthe multiple posture states during a programming session, e.g.,in-clinic or remotely. The patient 12 then can leave the programmingsession with a baseline set of therapy parameters for some or all of thepreviously defined posture states. Saving the current therapy settingsto multiple posture states selected for posture-responsive stimulationmay provide an initial starting point for therapy delivery for each ofthe posture states and decrease initial clinician programming time.Allowing a clinician to set a baseline therapy, e.g., for multipleposture states, may decrease upfront programming time by the clinicianwhile allowing further refinement by the patient 12 as needed.

Patient 12 may later refine therapy parameter values associated with oneor more posture states using patient programmer 30, e.g., in the courseof a therapy session. In the therapy session, the IMD 14 or programmer30 may apply parameter values specified in a previous programmingsession to deliver therapy to the patient 12 for different posturestates. Although posture states are defined, some parameter values maybe undefined for some posture states. A patient 12 may set uniquetherapy parameter values for a given posture state currently occupied bythe patient, e.g., by entering therapy parameter values or makingtherapy parameter value adjustments. The current posture state may havebeen initially defined with a baseline therapy or left with at leastsome parameter values undefined. In some embodiments, patient 12 may bepermitted to associate a current therapy parameter value or set of atherapy parameter values applied for the current posture state with aposture state regardless of whether the patient is actually positionedin that posture states. In some cases, patient 12 may associate thecurrent therapy parameter value, used to define delivery of therapy tothe patient for the current posture state, with multiple posture statesthat are different from the posture state presently occupied by thepatient. Hence, patient 12 may be permitted to associate a currenttherapy parameter value for a currently occupied posture state withanother posture state that is not currently occupied by the patient andis different from the currently occupied posture state.

For example, patient 12 may adjust one or more therapy parameter valueswhile sitting upright. The therapy adjustments may be associated withthe upright posture state, e.g., using association logic or techniquessuch as the search timer and stability timer. Patient 12 may feelcomfortable with the therapy parameter value or values for the currentupright posture state, and wish to use or try the same therapy parametervalue or values for other posture states. As another example, patient 12may recognize that he desires a lower amplitude when lying down, e.g.,in a sleeping position, than when sitting upright. Patient 12 maydecrease the amplitude associated with the upright posture state to alower amplitude that he would prefer to receive when sleeping andassociate that amplitude with one or more lying down posture states,e.g., lying back, lying front, lying left, and lying right. In eithercase, a patient may associate the current therapy parameter value forthe current posture with a different posture state via patientprogrammer 30. Patient programmer 30 or IMD 14 may then define therapyto be delivered for the different posture state based on the newlyassociated therapy parameter value or values.

Screen 300 or a modified version of screen 300 may be displayed onpatient programmer 30 to permit patient 12 to associate the patientadjustment with a posture state other than the posture state patient 12currently occupies. This may allow patient 12 to define therapyparameter values for a posture state, e.g., posture or combination ofposture and activity, without having to occupy to the posture state.Upon association with a different posture state, the therapy parametervalue or values may be used to automatically define therapy to bedelivered when the patient later resides in the different posture state.Delivering therapy according to the set of therapy parameters values mayprovide an indication that the set of therapy parameter values are safefor patient 12. In general, patient 12 may be permitted to freely assigntherapy parameter values for a current posture state currently occupiedby the patient with other posture states. In some cases, however, suchassociations may be subject to conditions specified by a clinician, suchas therapy parameter value safety margins which may limit the level ofthe therapy parameter value, e.g., voltage or current amplitude, forsome posture states.

With further reference to FIG. 19, when a user selects a posture state,screen 300 displays a check mark in the box next to the name of theposture state within posture state selection list 240. Boxes withoutcheck marks are displayed next to unselected posture states. If a set ofposture states are linked together, when one posture state of the set oflinked posture states is selected, the remaining posture states of theset of linked posture states may be automatically selected.Additionally, screen 300 may only permit selection of posture statesthat have been selected for posture-responsive therapy. A user may alsouse cancel button 302 or confirm button 304 to cancel or confirm theselections made via posture state selection list 240 of screen 300.

Screen 300 may also indicate, for the selected group, which posturestates have been selected for posture-responsive therapy and/or whichposture states are associated with clinician-defined therapy parametervalues. In the example of FIG. 19, screen 300 includes a legend 306 thatexplains symbols and other notations used with posture state selectionlist 240. A posture state selected for posture-responsive therapy may bedesignated as automated. In some cases, the programmer may be configuredto prohibit overwriting of previously defined therapy parameters usingthe save feature. For example, a posture state associated with a set oftherapy parameter values such that each of the therapy parameters isdefined may be designated as clinician-defined. A posture state with oneor more therapy parameters that are not associated with a specific valuemay be designated as patient-defined. Hence, in some implementations,the ability to associate therapy parameter settings from current posturestate with other posture states may be limited to therapy parametervalues that are previously undefined, or extend to all therapy parametervalues.

As described above, screen 300 allows a user to associate therapyparameter values with a posture state without the patient being in thatposture state. A user may associate the therapy parameter valuescurrently being used to deliver therapy, e.g., for one posture state,with any one or more of the posture states selected forposture-responsive therapy. Delivering therapy according to the set oftherapy parameters values may provide an indication that the set oftherapy parameter values are safe for patient 12. Even though patient 12may not actually be in the posture state that the user associates withthe set of therapy parameter values when therapy is delivered, patient12 has felt the intensity of the therapy parameter values and may feelcomfortable applying the same stimulation for other posture states.

In the example illustrated in FIG. 19, a user may save a complete set oftherapy parameter values to a posture state such that a value is savedfor each therapy parameter, e.g., voltage or current amplitude, pulsewidth, pulse rate, electrode combination, electrode polarity or thelike. In some embodiments, a user may be permitted to save a subset ofthe therapy parameter values to a posture state. In this manner, some ofthe therapy parameter values may be defined and others undefined for aposture state. As another example, the clinician or other user ofclinician programmer 60 may not save any therapy parameters to a posturestate and, instead, allow patient 12 to define all of the therapyparameter values.

FIG. 20 is a conceptual illustration of posture cones used to defineposture states of patient 12 from a posture state sensor of a posturestate module, e.g., posture state module 86 of IMD 14 (FIG. 4) orposture state module 98 of IMD 26 (FIG. 5). FIG. 20 illustrates anexample posture state space 310 that is a three-dimensional space inwhich the posture state parameter value from the posture state sensor isplaced in relation to posture cones. Posture state space 310 issubstantially similar to posture state area 152 of FIG. 8B. However,posture space 310 includes an additional patient-defined posture state.In the example of FIG. 20, the additional patient-defined posture stateis a posture cone 312. Similarly to posture state area 152 of FIG. 8B,posture state space 300 includes upright cone 154, lying back cone 156,and lying front cone 158. Posture state space 300 also includeshysteresis zones where no posture cones are defined. In the example ofFIG. 20, the hysteresis zones are the spaces not occupied by a posturecone, e.g., upright cones 154, lying back cone 156, lying front cone158, and patient-defined cone 312.

In the example of FIG. 20, patient-defined cone 312 may be referred toas reclining cone 312, because it is located between upright cone 154and lying back cone 156 to indicate when patient 12 is reclining back.However, a variety of different posture states may be defined by patient12. If patient 12 occupies a posture state not contained within thedefined posture cones, e.g., upright cone 154, lying back cone 156, andlying front cone 158, patient 12 may create a new cone, such asreclining cone 312. In this manner, patient 12 may supplement a set ofpre-established posture states such as a set of pre-established posturestate definitions. In this case, the pre-established posture statedefinitions stored in memory of the programmer are posture state cones,e.g., upright cone 154, lying back cone 156, and lying front cone 158.

User interface 168 of patient programmer 30 may allow patient 12 oranother user to submit a request to update the set of pre-establishedposture state definition, e.g., by adding a new posture state. Inresponse to the request, the programmer updates the set ofpre-established posture state definitions. Based on the input frompatient 12, a new posture state definition is created, such as recliningcone 312. The patient input may specify the desired location of the newposture cone, e.g., by identifying the location on a graphicalrepresentation of posture state space 310 or any other suitablegraphical means displayed on patient programmer 30 or providing anindication to patient programmer 30 when patient 12 is in the desiredposture state. For example, if patient 12 provides an indication topatient programmer 30 when patient 12 is in the desired posture state,the processor 80 of IMD 14 or a processor of posture state module 86 maydetermine the output of the posture state module 86 when the indicationis received, and capture that information to define the posture statedefinition. For example, the new posture cone may be created based onthat output, which may comprise a sensed coordinate vector.

The cone angle D of reclining cone 312 may be predefined, determinedbased on an algorithm, or specified by patient 12. As one example,patient programmer 30 may require patient 12 to be positioned in the newposture state, e.g., reclining, when the request for a new posture stateis made. Patient programmer 30 may generate reclining cone 312 to extenda predetermined angle from both sides of the patient's position. Thepatient's position may correspond to center line 314 of reclining cone312, which may be determined by vector coordinates obtained from aposture state sensor such as an accelerometer.

As another example, patient programmer 30 may compare the requestedlocation of the new cone to the locations of adjacent cones. Patientprogrammer 30 may calculate cone angle D based on the angle between theadjacent cones 154 and 156 and the desired size of the hysteresis zonesbetween reclining cone 312 and adjacent cones 154 and 156. As yetanother example, patient 12 may indicate the boundaries of recliningcone 312. Patient 12 may assume a first position, indicate the firstposition as the starting point of reclining cone 312 via patientprogrammer 30, assume a second position, and indicate the secondposition as the ending point of reclining cone 312 via patientprogrammer 30.

Alternatively, patient 12 may graphically indicate the boundaries ofreclining cone 312 directly on user interface 168 of patient programmer30. For example, patient 12 could draw a cone or indicate a region ofthe cone with a stylus or other pointing or drawing tool in conjunctionwith a touch screen on patient programmer 30. Patient 12 could draw thecone or simply draw a ray to represent a central reference vector of thecone. In this case, programmer 30 could automatically apply a toleranceangle to the reference vector to define the cone. In some cases, patient12 could identify the tolerance angle. Upon defining the posture statedefinition, patient 12 could view the result, either as a final resultor a preliminary result that requires patient confirmation forexecution. In particular, patient programmer 30 may be configured topresent an illustration of the cone to the user.

In some examples, using programmer 30, a patient 12 may be permitted tocopy and paste an existing cone to create a new cone in a particularregion, or drag and drop an existing cone into a particular region.Also, patient programmer 30 may be configured to permit patient toresize existing cones by redefining cone angles or by manipulating oneor more handles or other control points on an existing cone or a newcone to expand or shrink the cone or its tolerance angle. As an example,a cone may have control points associated with rays defining the outersurface of the cone, as a function of cone angle.

By dragging the control points with a stylus or other pointing device ina given direction, the patient 12 may increase or reduce the conetolerance angle. In some cases, a patient 12 may manipulate a controlpoint on one side of the cone to expand or shrink the cone angle in asymmetrical manner about the reference vector. Dragging and dropping,copying and pasting, expanding and shrinking, rotating, tilting, andother graphical utility operations may be used to create new cones, orresize new or existing cones. As an illustration, a patient 12 couldclick on an upright cone and specify a copy operation, and drag a copyof the cone to a desired location, possibly rotating the cone to adesired position.

As another example, patient programmer 30 may provide a drop down menuthat provides numerous graphical operations that can be chosen by apatient 12, such as cone shrinking, cone enlarging, or other operations.In some cases, a drop-down menu may permit a patient to select differentcone or cone angle sizes, such as small, medium or large. A variety ofgraphical utilities may be provided to the patient 12 via patientprogrammer 30 to permit the patient to flexibly and convenientlycustomize posture state definitions by modifying existing cones oradding new cones of desired size and position. Although cones aredescribed for purposes of illustration, other types of posture statesmay be suitable for graphical manipulation and definition by patient 12.

Allowing patient 12 to define posture states may be particularly usefulwhen patient 12 frequently occupies a posture state not contained withina set of clinician-defined cones. Patient 12 may create posture statescorresponding to his typical activities, such as sitting, reading, anddriving. One or more of the therapy parameter values used to delivertherapy when the new postures state is defined may optionally beassociated with the new posture state for posture-responsive therapy,e.g., to provide one or more initial therapy parameter values for thenew posture state. The new posture state may be selected forposture-responsive therapy, e.g., automatically in response to creationof the new posture state or manually in response to patient input. Inthis manner, a set of therapy parameter values may be associated withthe new posture state. Upon subsequent detection of the new posturestate, therapy may be delivered according to the set of therapyparameter values. Additionally, therapy adjustments made when patient 12is in or transitioning to the new posture state may be associated withthe new posture state.

Patient 12 is not limited to defining posture states outside of theclinician-defined posture states. In some embodiments, patient 12 may beallowed to modify existing posture states. For example, if the therapyparameter values associated with upright cones 154 are being deliveredwhen patient 12 is reclining, patient 12 may modify cone angle A, and/orthe location of center line 153A. By allowing patient 12 to modifyexisting posture state definitions such as existing, pre-establishedcones, patient 12 may adapt therapy delivery to the changing needs ofpatient 12. As one example, if the upright posture of patient 12 changesfrom slouching to more upright over time, allowing patient 12 to adjustexisting upright cones 154 may improve therapy delivery to patient 12.

FIG. 20 and its corresponding description refer primarily to posturestate cones for purposes of example. However the concept of updatingposture state definitions, e.g., by creating new posture states and/ormodifying existing posture states, may be applicable to other types ofposture state definitions. In this manner, although a center line andcone angle are used to describe posture state cones for purposes ofillustration, a posture state may be more generally defined by a posturecoordinate vector and a tolerance, which may define the boundaries of aposture state.

In other examples, posture state definitions may be updatedautomatically by programmer 30, programmer 60 or IMD 14. For example,IMD 14 may record and analyze patient postures and, optionally, therapyadjustment data. The patient postures may be indicated by sensedcoordinate vectors received from an accelerometer or other posturesensor of posture state module 86. Based on this data, IMD 14 mayautomatically update posture state definitions, e.g. by merging,splitting, expanding, shrinking, or creating posture states. Althoughthe techniques for automatically updating posture state definitionsdescribed with respect to FIGS. 21-23 primarily refer to IMD 14, suchtechniques may more generally be performed by IMD 14, IMD 28, orexternal programmer 20, e.g., patient programmer 30 or clinicianprogrammer 60.

IMD 14 may record and store, e.g., within memory 82, posture vectors orother data indicative of the orientation of patient 12, as an indicationof patient postures. IMD 14 may continuously or periodically record thepostures of patient 12. As one example, IMD 14 may record the posturevector of patient 12 substantially continuously, e.g., continuously orvia periodic sampling, to determine which posture vectors patient 12frequently occupies. IMD 14 may analyze this information to determinewhether any posture state definitions should be updated.

For example, IMD 14 may identify a set of the recorded posture vectorsthat fall within a defined posture state. If the identified set of therecorded posture vectors predominantly fall within a portion of thedefined posture state, as automatically determined by IMD 14, IMD 14 mayshrink the posture state definition such that its boundaries moreclosely match the portion where the posture vectors predominantly fall,e.g., automatically or upon confirmation for a user. As illustrated inthe example of FIG. 21, posture state cone 390A may initially be definedby center line 392E, as referred to as posture state reference vector392E, and cone angle E. However, based on recorded posture vectors overa period of time, IMD 14 may redefine the posture state definition togenerate a modified posture state cone 390B defined by center line 392F,also referred to as posture state reference vector 392F, and cone angleF.

Posture state cone 390B may represent the portion of posture state cone390A where the recorded posture vectors predominantly fall. For example,IMD 14 may automatically define the boundaries of modified posture statecone 390B such that at least a specified percentage, e.g., 80-100%, ofthe recorded posture vectors for the posture state cone 390A fall withinthe smaller posture state cone 390B. IMD 14 may be configured toautomatically evaluate redefinition of posture state cone 390A on aperiodic basis or after a specified number of posture vectors have beenreceived for posture state cone 390A. By shrinking a posture statedefinition, IMD 14 may make greater use of hysteresis zones betweenposture state definitions. Although posture state cones are illustratedin the example of FIG. 21, other types of posture state definitions mayalso be used. In this manner, redefining a boundary of a posture statemay more generally comprise redefining a posture state reference vectorand/or a tolerance, e.g., a distance, angle, or cosine value.

As another example, IMD 14 may record the orientation of patient 12 eachtime IMD 14 receives a patient therapy adjustment, e.g., from externalprogrammer 20. For example, IMD 14 may record the posture vector thatpatient 12 occupies when a therapy adjustment is received and associatedwith the posture state, e.g., according to association techniquesdescribed in this disclosure. The posture vector may be a posture vectorthat patient 12 occupies when the therapy adjustment is received or aposture vector to which patient 12 transitions following the therapyadjustment. In some examples, more than one posture vector may berecorded for each therapy adjustment. IMD 14 may also record therapyadjustment data. For example, IMD 14 may store, e.g., within memory 82,associations between recorded posture vectors and therapy adjustmentdata. IMD 14 may analyze the vectors and therapy parameter valuesassociated with therapy adjustments to determine whether to updateposture state definitions.

FIG. 22 is a flow diagram illustrating an example method for updatingposture state definitions when a recorded posture vector associated witha therapy adjustment falls within a defined posture state. Similarly,FIG. 23 is a flow diagram illustrating an example method for updatingposture state definitions when a recorded posture vector associated witha therapy adjustment falls outside of the defined posture states. IMD 14may determine whether a posture vector associated with a therapyadjustment falls within any of the defined posture states.

If IMD 14 determines that a posture vector associated with a therapyadjustment falls within a defined posture state, IMD 14 may determinewhether the difference between an adjusted therapy parameter valueentered by patient 12 and associated with the posture vector and atherapy parameter value associated with the posture state is less than athreshold difference (400), as illustrated in FIG. 22. By determiningwhether the difference between an adjusted therapy parameter valueassociated with the posture vector and a therapy parameter valueassociated with the posture state is less than a threshold difference,IMD 14 may determine how closely the adjusted therapy parameter valuecompares to the therapy parameter value associated with the posturestate.

In some examples, IMD 14 may compare the difference in the values of onespecified therapy parameter, such as amplitude, to a threshold value. Inother examples, IMD 14 may compare the difference in the values of eachof a plurality of therapy parameters to one or more threshold values.For example, IMD 14 may compare the difference in each therapy parametervalue to a respective threshold value and determine that the differenceexceeds a threshold difference if the difference in one or more of theindividual therapy parameter values exceeds its respective thresholdvalue. As another example, IMD 14 may combine the individual differencesof each of the plurality of therapy parameter values, e.g., using aweighted summation, to determine an overall difference in the therapyparameters values. IMD 14 may compare the overall difference to anoverall threshold value.

A difference between the therapy parameter values that exceeds thethreshold value may signify that the therapy adjustment is substantiallydifferent from the therapy parameter values stored in association withthe posture state. If the difference exceeds the threshold value, IMD 14may further examine therapy adjustments associated with posture vectorsthat fall within the posture state. More specifically, IMD 14 maydetermine whether any previously received therapy adjustments wereassociated with posture vectors that fall within the posture state(402).

If there are not any previously received therapy adjustments associatedwith posture vectors that fall within the posture state, IMD 14 mayassociate the therapy adjustment with the posture state (404). In thismanner, the previously undefined therapy parameter value for the posturestate is defined according to the patient therapy adjustment. Thetherapy parameter values previously associated with the posture state,if available, may have been initial values set during the initialprogramming of IMD 14. IMD 14 may store the adjusted therapy parametervalues and the associated posture vector in association with the posturestate.

If there are one or more previously received therapy adjustmentsassociated with posture vectors that fall within the posture state, IMD14 may analyze the previously and currently received therapy adjustments(406). For example, IMD 14 may analyze where the posture vectors arepositioned and the therapy parameter values associated with the posturevectors. For example, IMD 14 may identify two posture vectors separatedby a substantial distance with substantially different therapy parametervalues.

As another example, IMD 14 may identify a first set of posture vectorsassociated with similar therapy parameter values concentrated in a firstregion of the posture state and a second set of posture vectorsassociated with similar therapy parameter values concentrated in asecond region of the posture state. The therapy parameter valuesassociated with the first set of posture vectors may be substantiallydifferent from the therapy values associated with the second set ofposture vectors.

Based on the analysis, IMD 14 may determine whether the therapyadjustments and corresponding posture state vectors indicate multipletrends in the therapy adjustments (408). For example, IMD 14 mayidentify different regions of the posture state that exhibit differenttrends in therapy adjustments. If IMD 14 does not identify differenttrends in the therapy adjustments, IMD 14 may associate the therapyadjustment with the posture state (404). If IMD 14 identifies differenttrends in the therapy adjustments, IMD 14 may split the posture stateinto two or more new posture states according to the identified trends(410). For example, postures initially assigned to a common posturestate may be reassigned by splitting such that some of the postures areassigned to one posture state and other postures are assigned to adifferent posture state. IMD 14 may also associate the current therapyadjustment with the appropriate one of the new posture states (412).

Returning back to determining whether the difference between an adjustedtherapy parameter value associated with the posture vector and a therapyparameter value associated with the posture state is less than athreshold difference (400), if IMD 14 determines that the difference isless than a threshold difference, IMD 14 may further examine whether theposture state in which the posture vector falls is similar to anyposture states positioned close by. For example, IMD 14 may determine ifthe distance between the posture state and any of its adjacent posturestates is below a threshold distance (414). If none of the adjacentposture states are within a threshold distance of the posture state inwhich the posture vector lies, IMD 14 may associate the therapyadjustment with the posture state (404).

If one or more of the adjacent posture states are within a thresholddistance of the posture state in which the posture vector lies, IMD 14may determine whether the therapy parameter values associated with theclosely located posture states are substantially similar to the adjustedtherapy parameter values. More specifically, IMD 14 may determinewhether the difference between one or more of the adjusted therapyparameter values and one or more therapy parameter values associatedwith an adjacent posture state is below a threshold difference (416). Ifmore than one adjacent posture state is within a threshold distance ofthe posture state in which the posture vector lies, IMD 14 may make aseparate determination for each of the adjacent posture states that fallwithin the threshold distance.

The method of determining whether the difference between one or more ofthe adjusted therapy parameter values and one or more therapy parametervalues associated with an adjacent posture state is below a thresholddifference (416) may be substantially similar to the method describedwith respect to determining whether the difference between an adjustedtherapy parameter value associated with the posture vector and a therapyparameter value associated with the posture state is less than athreshold difference (400). For example, IMD 14 may compare values forone or multiple therapy parameters and the threshold value may bespecific to a therapy parameter or an overall threshold value.

If none of adjacent posture states within the threshold distance areassociated with therapy parameter values substantially similar to theadjusted therapy parameter values, IMD 14 may associate the therapyadjustment with the posture state in which the posture vector lies(404). If one or more of the adjacent posture states within thethreshold distance are associated with therapy parameter valuessubstantially similar to the adjusted therapy parameter values, IMD 14may merge the one or more adjacent postures states that are within thethreshold distance and are associated with the substantially similartherapy parameter values with the posture state in which the posturevector lies (418). For example, IMD 14 may merge the one or moreadjacent postures by associating them with common, merged posture state.IMD 14 may also associate the adjusted therapy parameter values with themerged posture state (420).

FIG. 23 is a flow diagram illustrating an example method for updatingposture state definitions when a recorded posture vector associated witha therapy adjustment falls outside of the defined posture states. IMD 14may determine whether the posture vector is within a threshold distanceof any of the posture states adjacent to the posture vector (430). Ifnone of the existing posture states adjacent to the posture vector arewithin a threshold distance of the posture vector, IMD 14 may create anew posture state that includes the posture vector (432). For example,IMD 14 may generate the posture state to extend a predetermined amount,e.g., a predetermined angle or distance, from both sides of the posturevector. As another example, IMD 14 may compare the location of theposture vector to the locations of adjacent posture states. IMD 14 maydetermine the boundaries of the new posture state based on the distancebetween the posture vector and surrounding posture states and thedesired size of the hysteresis zones between posture states. IMD 14 mayalso associate the therapy adjustment with the new posture state (434).

If the posture vector is within a threshold distance of one or moreposture states adjacent to the posture vector, IMD 14 may examinewhether any of the posture states within the threshold distance areassociated with therapy parameter values similar to the adjusted therapyparameter values. More specifically, IMD 14 may determine whether thedifference between an adjusted therapy parameter value associated withthe posture vector and a therapy parameter value associated with theposture state that falls within a threshold distance of the posturevector is less than a threshold difference (436). As described withrespect to determining whether the difference between an adjustedtherapy parameter value associated with the posture vector and a therapyparameter value associated with the posture state is less than athreshold difference (400), IMD 14 may compare values for one ormultiple therapy parameters and the threshold value may be specific to atherapy parameter or an overall threshold value.

If none of the posture states within the threshold distance of theposture vector are associated with therapy parameter valuessubstantially similar to the adjusted therapy parameter values, IMD 14may create a new posture state that includes the posture vector (432)and may also associate the therapy adjustment with the new posture state(434). If a posture state within the threshold distance of the posturevector is associated with therapy parameter values substantially similarto the adjusted therapy parameter values, IMD 14 may expand theboundaries of the posture state to include the posture vector (438). Ifmultiple posture states within the threshold distance of the posturevector are associated with therapy parameter values substantiallysimilar to the adjusted therapy parameter values, IMD 14 may merge themultiple posture states in addition to expanding the boundaries of theposture state to include the posture vector. IMD 14 may also associatethe therapy adjustment with the expanded posture state (440).

In summary, as described in this disclosure, various posture statemanagement techniques may be implemented in a clinician programmer,patient programmer and/or IMD to facilitate definition of posture statesand associated therapy parameter values for use in posture responsivetherapy, i.e., therapy in which therapy parameter values are selected oradjusted according to a detected posture state of a patient.

For example, when there is no defined posture responsive therapy for agiven posture state, and a patient makes a therapy adjustment whileoccupying that posture state, a programmer or IMD may associate theadjustment with the posture state to define the therapy for that posturestate such that a therapy parameter value indicated by the adjustment isdelivered that next time the patient occupies that posture state. Inparticular, upon subsequently detecting the posture state, postureresponsive therapy is auto-enabled to apply the defined therapy with theassociated therapy parameter value. If the patient initially leaves theclinic with posture-responsive therapy non-enabled for some posturestates, once the patient makes an adjustment within a posture state, aprogrammer or IMD may auto-enable that posture state forposture-responsive therapy and return the amplitude to the patientdefined value on subsequent returns to that posture state.

In some embodiments, posture states may be linked to tie multipleposture states to common set of posture reference data and a common setof therapy parameter values. This may, in effect, merge multiple posturecones for purposes of posture state-based selection of therapy parametervalues. For example, all lying posture state cones (back, front, left,and right) could be treated as one cone or donut/toroid. One programgroup or common set of therapy parameter values may apply to all posturestates in the same merged cone, according to the linking status of theposture states, as directed via a programmer.

Linking of posture states also may permit a therapy parameter valueadjustment in one posture state to be associated with multiple posturestates at the same time. For example, the same amplitude level for oneor more programs may be applied to all of the posture states in a linkedset of posture states. Alternatively, the donut or toroid may be dividedinto sectional segments that correspond to different posture states,such as “Lying (Back)”, “Lying (Front)”, “Lying (Right)”, and “Lying(Left)”. In this case, different posture reference data and therapyparameter values may be assigned to the different sectional segments ofthe donut/toroid.

As an additional feature, a clinician or patient may be permitted, via aclinician and/or patient programmer, to define new posture states thatmay not be included in an initial set of posture states. If a patientfrequently (or not so frequently) occupies an undefined posture state,e.g., reclining, sitting, reading, driving, for example, the clinicianor patient may be permitted to assign a specific posture state andassociate clinician- or patient-selected therapy parameter values withthe newly defined posture state. In effect, a new posture state cone maybe dynamically generated based on patient selection of the newly definedposture state.

Additionally or alternatively, an external programmer, e.g., patient orclinician programmer, or an IMD may automatically update posture statedefinitions. For example, a programmer or IMD may record and analyzepatient posture and, optionally, therapy adjustment data. Based on thisdata, IMD 14 may update posture state definitions, e.g. by merging,splitting, expanding, shrinking, or creating posture states. In thismanner, posture state definitions may be dynamic and customizable

As a further feature, various therapy parameter values may beinitialized or adjusted for different posture states without the patientactually residing in the posture states. For example, a clinician orpatient may be permitted to set initial therapy parameter values oroverride/adjust existing parameter values for some or all posture stateswithout requiring the patient to actually occupy the posture state. Aclinician or patient may also be permitted to save therapy settings tomultiple posture states at once. In this manner, the clinician orpatient may quickly set therapy parameter values to desired values.

FIGS. 24-26 are flow charts illustrating some of the techniquesdescribed in this disclosure. In the example of FIG. 24, a programmer isused to link posture states (450), select link-active group(s) for thelinked posture states (452), select therapy parameter values, e.g., forone of the linked posture states (454), and automatically associate thetherapy parameter values with each of the linked posture states (456).The IMD may be programmed to apply this linking information. Then, inthe course of posture responsive therapy, the IMD may detect posturestates (458) and apply common therapy parameter values associated withlinked posture states for therapy (such as electrical neurostimulation)delivered to the linked posture states (460).

FIG. 25 illustrates a programmer being configured to specify programmingof an IMD such as posture-responsive therapy, i.e., delivery ofdifferent therapy with different therapy parameter values based onposture state. One or more therapy parameter values are left undefinedfor at least some posture states (470). Thereafter, if a programmer orthe IMD detects a patient adjustment to therapy parameter values whilethe patient occupies a posture state for which posture responsivetherapy for which therapy parameter values are undefined (472), the IMDor programmer may automatically associate the patient adjusted therapyparameter values with the posture state (474) such that postureresponsive therapy according to the patient adjusted therapy parametersvalues is active for that posture state in the future (476). Then, upondetecting that posture state in the future (478), the IMD may applytherapy according to the therapy parameter values associated with theposture state based on the patient adjustment received when the one ormore therapy parameter values were undefined for that posture state(480). Hence, a posture state may be changed from having one or moretherapy parameter values undefined to having a complete set of therapyparameter values defined for posture state-responsive therapy.

FIG. 26 illustrates detection of a patient adjustment, while occupying aposture state, to one or more therapy parameter values, such asamplitude, e.g., by a programmer or IMD (490), application of thepatient adjustment to adjust therapy parameter values for other posturestates that are linked with the posture state (492). When posture statesare detected during the course of posture-responsive therapy (494), aprogrammer or IMD may cause the IMD to deliver therapy that applies thepatient adjustment-based therapy parameter values for therapy deliveredwhen the patient is in the linked posture states (496).

The techniques described in this disclosure may be implemented, at leastin part, in hardware, software, firmware or any combination thereof. Forexample, various aspects of the techniques may be implemented within oneor more microprocessors, digital signal processors (DSPs), applicationspecific integrated circuits (ASICs), field programmable gate arrays(FPGAs), or any other equivalent integrated or discrete logic circuitry,as well as any combinations of such components, embodied in programmers,such as physician or patient programmers, stimulators, or other devices.The term “processor” or “processing circuitry” may generally refer toany of the foregoing logic circuitry, alone or in combination with otherlogic circuitry, or any other equivalent circuitry.

When implemented in software, the functionality ascribed to the systemsand devices described in this disclosure may be embodied as instructionson a computer-readable medium such as random access memory (RAM),read-only memory (ROM), non-volatile random access memory (NVRAM),electrically erasable programmable read-only memory (EEPROM), FLASHmemory, magnetic media, optical media, or the like. The instructions maybe executed to support one or more aspects of the functionalitydescribed in this disclosure.

In addition, it should be noted that the systems described herein maynot be limited to treatment of a human patient. In alternativeembodiments, these systems may be implemented in non-human patients,e.g., primates, canines, equines, pigs, and felines. These animals mayundergo clinical or research therapies that may benefit from the subjectmatter of this disclosure.

Many embodiments of the disclosure have been described. Variousmodifications may be made without departing from the scope of theclaims. These and other embodiments are within the scope of thefollowing claims.

1. A method comprising: defining a plurality of posture states for apatient; defining therapy parameter values for at least some of theposture states; receiving patient input indicating a value for apreviously undefined therapy parameter value for one of the definedposture states while the patient is in the respective posture state ortransitioning to the respective posture state; and defining thepreviously undefined therapy parameter value for the respective posturestate based on the patient input.
 2. The method of claim 1, wherein thepreviously undefined therapy parameter value comprises at least one ofan amplitude value, a pulse width value, a pulse rate value, anelectrode combination, or an electrode polarity.
 3. The method of claim1, further comprising requesting that the patient confirm that thepreviously undefined therapy parameter value should be defined for therespective posture state based on the patient input, and defining thepreviously undefined therapy parameter value for the respective posturestate based on both the patient input and the patient confirmation. 4.The method of claim 1, wherein defining the previously undefined therapyparameter comprises automatically defining the previously undefinedtherapy parameter value for the respective posture state.
 5. The methodof claim 1, further comprising: detecting the respective posture stateof the patient; and delivering therapy to the patient using the therapyparameter value defined based on the patient input in response to thedetection.
 6. The method of claim 5, wherein delivering therapycomprises delivering electrical stimulation therapy to the patient viaan implantable medical device.
 7. The method of claim 1, furthercomprising: receiving patient input indicating values for a plurality ofpreviously undefined therapy parameter value for a plurality of thedefined posture states while the patient is in the respective posturestates or transitioning to the respective posture states; and definingthe previously undefined therapy parameter values for each of therespective posture states based on the patient input.
 8. An externalprogrammer for an implantable medical device, the programmer comprising:a memory that stores a definition of a plurality of posture states for apatient and a definition of therapy parameter values for at least someof the posture states; a user interface that receives patient inputindicating a value for a previously undefined therapy parameter valuefor one of the defined posture states while the patient is in therespective posture state or transitioning to the respective posturestate; and a processor that defines the previously undefined therapyparameter value for the respective posture state based on the patientinput.
 9. The external programmer of claim 8, wherein the previouslyundefined therapy parameter value comprises at least one of an amplitudevalue, a pulse width value, a pulse rate value, an electrodecombination, or an electrode polarity.
 10. The external programmer ofclaim 8, wherein the user interface generates a request that the patientconfirm that the previously undefined therapy parameter value should bedefined for the respective posture state based on the patient input, andthe processor defines the previously undefined therapy parameter valuefor the respective posture state based on both the patient input and thepatient confirmation.
 11. The external programmer of claim 8, whereinthe processor automatically defines the previously undefined therapyparameter value for the respective posture state.
 12. The externalprogrammer of claim 8, wherein the programmer programs the implantablemedical device to detect the respective posture state of the patient,and deliver electrical stimulation therapy to the patient using thetherapy parameter value defined based on the patient input in responseto the detection.
 13. The external programmer of claim 8, wherein theuser interface receives patient input indicating values for a pluralityof previously undefined therapy parameter values for a plurality of thedefined posture states while the patient is in the respective posturestates or transitioning to the respective posture states, and theprocessor defines the previously undefined therapy parameter values foreach of the respective posture states based on the patient input.
 14. Asystem comprising: a memory that stores a definition of a plurality ofposture states for a patient and a definition of therapy parametervalues for at least some of the posture states; an external programmercomprising a user interface that receives patient input indicating avalue for a previously undefined therapy parameter value for one of thedefined posture states while the patient is in the respective posturestate or transitioning to the respective posture state; a processor thatdefines the previously undefined therapy parameter value for therespective posture state based on the patient input; and an implantablemedical device that detects the posture states, and delivers therapy tothe patient input using the therapy parameter values defined for thedetected posture states.
 15. The system of claim 14, wherein thepreviously undefined therapy parameter value comprises at least one ofan amplitude value, a pulse width value, a pulse rate value, anelectrode combination, or an electrode polarity.
 16. The system of claim14, wherein the user interface generates a request that the patientconfirm that the previously undefined therapy parameter value should bedefined for the respective posture state based on the patient input, andthe processor defines the previously undefined therapy parameter valuefor the respective posture state based on both the patient input and thepatient confirmation.
 17. The system of claim 14, wherein the processorautomatically defines the previously undefined therapy parameter valuefor the respective posture state.
 18. The system of claim 14, whereinthe programmer programs the implantable medical device to delivertherapy to the patient using the therapy parameter values defined forthe posture states.
 19. The system of claim 14, wherein the userinterface receives patient input indicating values for a plurality ofpreviously undefined therapy parameter value for a plurality of thedefined posture states while the patient is in the respective posturestates or transitioning to the respective posture states, and theprocessor defines the previously undefined therapy parameter values foreach of the respective posture states based on the patient input. 20.The system of claim 14, wherein the implantable medical device comprisesthe processor.
 21. The system of claim 14, wherein the externalprogrammer comprises the processor.
 22. The system of claim 14, whereinthe external programmer comprises at least one of a patient programmeror a clinician programmer.
 23. The system of claim 14, wherein thetherapy delivered by the implantable medical device comprises electricalstimulation therapy.
 24. A system comprising: means for defining aplurality of posture states for a patient; means for defining therapyparameter values for at least some of the posture states; means forreceiving patient input indicating a value for a previously undefinedtherapy parameter value for one of the defined posture states while thepatient is in the respective posture state or transitioning to therespective posture state; and means for defining the previouslyundefined therapy parameter value for the respective posture state basedon the patient input.
 25. The system of claim 24, wherein the previouslyundefined therapy parameter value comprises at least one of an amplitudevalue, a pulse width value, a pulse rate value, an electrodecombination, or an electrode polarity.
 26. The system of claim 24,further comprising means for requesting that the patient confirm thatthe previously undefined therapy parameter value should be defined forthe respective posture state based on the patient input, and means fordefining the previously undefined therapy parameter value for therespective posture state based on both the patient input and the patientconfirmation.
 27. The system of claim 24, wherein the means for definingthe previously undefined therapy parameter comprises means forautomatically defining the previously undefined therapy parameter valuefor the respective posture state.
 28. The system of claim 24, furthercomprising: means for detecting the respective posture state of thepatient; and means for delivering therapy to the patient using thetherapy parameter value defined based on the patient input in responseto the detection.
 29. The system of claim 28, wherein the means fordelivering therapy comprises means for delivering electrical stimulationtherapy to the patient via an implantable medical device.
 30. The systemof claim 24, further comprising: means for receiving patient inputindicating values for a plurality of previously undefined therapyparameter value for a plurality of the defined posture states while thepatient is in the respective posture states or transitioning to therespective posture states; and means for defining the previouslyundefined therapy parameter values for each of the respective posturestates based on the patient input.